Data from 2101 patients and 3521 eyes treated with LipiFlow indicate that a single 12-min LipiFlow treatment safely improves signs and symptoms of meibomian gland dysfunction. |
The benefits of a single LipiFlow persist up to 3 years in some cases. |
The majority of studies evaluating safety reported no discomfort or pain associated with LipiFlow treatment, which supports the patient acceptability of LipiFlow therapy. |
While some studies showed that compliant daily eyelid hygiene, warm compress, and/or massage had a similar benefit to a single LipiFlow, these treatments were limited by inconvenience, discomfort, and non-compliance. |
Introduction
Methods
Search engine | Search terms | Number of articles retrieved | Number met inclusion criteria |
---|---|---|---|
PubMed | S1, S3 | 47 | 41 |
PubMed | S1, S4 | 36 | 35 |
PubMed | S1, S5 | 36 | 33 |
PubMed | S1, S6 | 29 | 28 |
PubMed | S2, S3 | 13 | 12 |
PubMed | S2, S4 | 2 | 1 |
PubMed | S2, S5 | 13 | 11 |
PubMed | S2, S6 | 7 | 7 |
OVID, Scopus, Springer Books, Cochrane Library | S1, S3 | 105 | 68 |
OVID, Scopus, Springer Books, Cochrane Library | S1, S4 | 85 | 54 |
OVID, Scopus, Springer Books, Cochrane Library | S1, S5 | 54 | 27 |
OVID, Scopus, Springer Books, Cochrane Library | S1, S6 | 65 | 36 |
OVID, Scopus, Springer Books, Cochrane Library | S2, S3 | 26 | 15 |
OVID, Scopus, Springer Books, Cochrane Library | S2, S4 | 24 | 12 |
OVID, Scopus, Springer Books, Cochrane Library | S2, S5 | 27 | 12 |
OVID, Scopus, Springer Books, Cochrane Library | S2, S6 | 25 | 9 |
Results
Dry Eye/MGD
Randomized Controlled Trials
Author/design/country | Patients (eyes)/age, mean (SD) | Last FU | Study arms | MG function Mean (SD) | Patient-reported outcomes Mean (SD) | NIKBUT/TBUT Mean (SD) | Staining | Overall conclusion and safety | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
Meng 2023 [22] Prospective, randomized, observer-masked China | N = 50 patients with MGD; LF: N = 25 patients (50 eyes), 58 (12) years; CL: N = 25 patients (50 eyes), 58 (12) years | 3 months | Single 12-min LF Tx CL: Lid warming BID with EyeGiene Insta-Warmth patch and massage for 2 weeks | MGSS LF:8.8 (2.2) CL: 9.5 (3.1) MGYLS LF: 3.7 (0.85) CL: 4.1 (1.1) | MGSS LF:12.8 (3.9)* CL: 10.2 (3.3) MGYLS LF:5.5 (1.2)*† CL: 4.4 (1.2) | SPEED LF: 7.1 (2.7) CL: 7.2 (2.2) | SPEED LF: 3.8 (1.5)*† CL: 6.6 (2.8) | TBUT LF: 2.3 (0.96) CL: 2.7 (1.4) | TBUT LF: 5.6 (2.2)*† CL: 4.0 (1.9)* | Corneal LF: 2.8 (1.8) CL: 2.2 (1.3) | Corneal LF: 1.2 (1.2)* CL: 1.2 (1.2) | LF Tx can ameliorate subjective systems of MGD and markedly improve MG function for at least 3 months. Safety NR |
Wesley 2022 [23] Prospective, randomized, multicenter, assessor-masked, parallel group USA | N = 236 patients with MGD; LF: 117 patients (234 eyes), 56 (14) years; iLUX: N = 119 (238 eyes), 58 (13) years | 12 months | Single 12-min LF Tx Single Tx Systane iLux Dry Eye System thermal pulsation Note: LF was the control | MGSS LF: 6.5 (3.8) iLux: 6.6 (3.7) | MGSS LF: 23.4 (11.4) iLux: 22.9 (11.3) | IDEEL-SB LF: 57.2 (14.6) iLux: 55.8 (15.9) | IDEEL-SB LF: 36.0 (18.1) iLux: 34.4 (16.7) | NIKBUT LF: 8.0 (3.0) iLux: 8.0 (3.0) | NIKBUT LF: 10.1 (4.0) iLux: 10.7 (4.6) | Corneal LF: 1.9 (2.4) iLux: 2.1 (2.9) | Corneal LF: 0.6 (1.2) iLux: 0.7 (1.5) | iLux was noninferior to LF AEs None No significant biomicroscopy findings |
Holland 2022 [24] Randomized single-masked, multicenter, non-inferiority, post-market USA | N = 235 patients with DED and MGD, LF:120 patients (240 eyes), 55 (15) years TearCare: 115 patients (230 eyes), 57 (14) years | 1 month | Single 12-min LF Tx Single 15-min Tx with TearCare | NR | NR | OSDI LF:51.7 (15.3) TearCare: 51.7 (14.8) SANDE LF:77.2 (15.8) TearCare: 70.6 (16.8) | OSDI LF:27.1 (19.0)* TearCare: 22.6 (17.2)*§ SANDE LF:34.0 (28.1)* TearCare: 29.4 (26.6)* | NR | NR | NR | NR | LF and the TearCare consistently improved DED symptoms. Safety NR |
Li 2021 [25] Prospective, randomized, observer-masked China | N = 54 patients with MGD (108 eyes), LF:54 eyes, 42 (11) years MiboFlo: 54 eyes, 44 (11) years | 2 months after first Tx | Single 12-min LF Tx MiboFlo ThermoFlo Tx, three 10-min Tx, each 2 weeks apart. Tx was instantly followed by eyelid compression Note: LF was the control | MGSS LF: 11.0 (3.8) MiboFlo: 9.2 (3.7) MGYLS LF: 8.4 (3.7) MiboFlo: 8.7 (3.6) | MGSS LF: 4.8 (2.2)* MiboFlo: 4.8 (2.2)* MGYLS LF: 2.9 (2.8)* MiboFlo: 5.1 (2.3)* | OSDI LF: 46.1 (17.7) MiboFlo: 44.3 (1.0) | OSDI LF: 30.6 (19.9)* MiboFlo: 28.7 (18.2)* | NIKBUT LF: 5.8 (3.0) MiboFlo: 6.4 (3.5) | NIKBUT LF: 5.9 (2.7) MiboFlo: 6.0 (2.7) | Corneal LF: 0.38 (0.63) MiboFlo: 0.16 (0.43) | Corneal LF: 0.18 (0.50) MiboFlo: 0.02 (0.15) | OSDI, MGYLS, and MGSS improved from BL in both groups, and improvements were maintained at 2 months AEs None No safety-related changes in IOP or VA |
Gupta 2022 [26] Randomized, masked, multicenter, controlled USA | N = 141 patients with DED; LF:72 patients (136 eyes), 52 (15) years; TearCare: 69 patients (134 eyes), 56 (14) years | 1 month | Single 12-min LF Tx Single 15-min Tx with TearCare plus MGX Note: LF was the control | MGSS LF:6.29 TearCare: 6.54 MGYLS LF:5.62 TearCare: 5.42 | MGSS LF:17.38* TearCare: 17.74* MGYLS LF:9.93* TearCare: 9.76* | OSDI LF:51.1 TearCare: 52.9 SANDE LF:73.2 TearCare: 68.4 | OSDI LF:27.7* TearCare: 24.2* SANDE LF:33.8* TearCare: 30.1* | TBUT LF:4.49 TearCare: 4.62 | TBUT LF:7.08* TearCare: 7.64* | Corneal LF:2.51 TearCare: 2.51 Conjunct LF:4.85 TearCare: 4.08 | Corneal LF:1.93 TearCare: 2.25* Conjunct LF:4.07 TearCare: 3.43* | TearCare was as effective as LF at alleviating signs and symptoms of DED Device-related AEs LF: N = 4 (N = 1 blepharitis, N = 2 foreign body sensation, and N = 1 severe eye dryness) TearCare: N = 3 (N = 1 SPK, N = 1 chalazion, N = 1 blepharitis) |
Booranapong 2020 [27] Prospective, observer-masked, randomized, controlled Thailand | N = 28 patients with moderate MGD (56 eyes), 54 (14) years; LF: 28 eyes; CL: contralateral eye (28 eyes) | 6 months | Single 12-min LF Tx CL: warm compress for 5 min BID for 3 months | MGYLS LF: 2.6 (2.8) CL: 2.5 (2.3) | MGYLS LF: 3.1 (2.1) CL: 2.7 (2.2) | SPEED LF: 9.5 (4.5) CL: 9.2 (4.4) | SPEED LF: 7.8 (5.3)* CL: 7.9 (5.8) | NR | NR | NR | NR | Both Tx relieved symptoms AEs LF: N = NR (device-related AE of eye discomfort/pain among patients with small eyes, narrow palpebral fissure, or deep-set eyes) |
Tauber 2020 [28] Randomized open-label, controlled, multicenter USA | N = 142 patients with DED and MGD, 55 (15) years LF: 70 patients (140 eyes), age NR; iLUX: N = 71 (142 eyes), age NR | 1 month | Single 12-min LF Tx Single Tx Systane iLux Dry Eye System thermal pulsation Note: LF was the control in this study | MGSS LF OD: 6.2 (4.9) LF OS: 6.4 (4.4) iLux OD: 6.0 (3.7) iLux OS: 5.9 (4.1) | MGSS LF OD: 24.3 (11.2) * LF OS: 23.3 (11.9) * iLux OD: 23.2 (12.1)* iLux OS: 23.8 (11.4)* | OSDI LF: 50.6 (18.7) iLux: 50.7 (18.6) | OSDI LF: 22.6 (19.8) * iLux: 19.5 (17.0)* | TBUT LF OD: 3.9 (2.0) LF OS: 3.8 (2.0) iLux OD: 3.9 (1.9) iLux OS: 3.7 (1.8) | TBUT LF OD: 6.6 (3.2) * LF OS: 6.5 (3.1) * iLux OD: 6.7 (3.7)* iLux OS: 6.5 (3.6)* | Corneal LF OD: 2.0 (2.2) LF OS: 2.5 (2.6) iLux OD: 2.1 (2.2) iLux OS: 2.3 (2.2) | Corneal LF OD: 0.9 (1.6) * LF OS: 1.2 (1.6) * iLux OD: 1.5 (2.4)* iLux OS: 1.4 (2.2)* | Both Tx had significant improvements in MG function and symptoms Device-related AEs LF: N = 0 iLux: N = 4 patients (N = 2 burning sensations without skin findings and N = 1 petechial hemorrhaging in lower lids, N = 1 transient decrease in BSCVA with findings consistent with exposure keratitis). No other abnormal findings |
Tauber 2020 [33] Single-center, 6-week, prospective, randomized, single-masked (investigator) USA | N = 50 patients with inflammatory MGD; LF: N = 25 patients (25 eyes), 67 (9) years; Liftegrast: N = 25 patients (25 eyes), 64 (8) years | 42 days | Single 12-min LF Tx plus warm compress/lid compression BID Lifitegrast ophthalmic solution 5% BID plus warm compress/ lid compression BID for 42 days | MGSS LF: 1.8 (0.55) Lifitegrast: 2.1 (0.49) MG patency LF: 5.4 (2.1) Lifitegrast: 4.8 (2.9) | MGSS LF: 1.9 (0.81) Lifitegrast: 1.8 (0.97) MG patency LF: 5.3 (2.6) Lifitegrast: 6.1 (2.8) | VAS Dryness LF: 1.9 (0.83) Lifitegrast: 2.4 (0.70) | VAS Dryness LF: 1.4 (0.71) Lifitegrast: 1.4 (0.91)† | NR | NR | Corneal LF: 0.84 (0.85) Lifitegrast: 1.5 (1.0) | Corneal LF: 0.96 (0.98) Lifitegrast: 1.0 (1.3)† | Lifitegrast significantly improved symptoms and signs compared with LF AEs None |
Ambaw 2020 [81] Single-center, investigator-masked interventional Singapore | N = 53 patients, LF: 35 patients (70 eyes); CL: 18 patients (36 eyes) | 3 months | Single 12-min LF Tx CL: eyelid warming (warm towel, Blephasteam or Eyegiene) 3x/day for 3 months | NR | NR | NR | NR | NR | NR | NR | NR | Both Tx reduced pro-inflammatory molecules generated by lipoxygenase and oxidative stress |
He 2018 [29] Single-blind, prospective, open-label, randomized, controlled China | N = 50 patients with MGD (100 eyes); LF: N = 25 patients (50 eyes), 40 (12) years; CL: N = 25 patients (50 eyes), 38 (12) years | 3 months | Single 12-min LF Tx 15-min Tx with warm eye patch (EyeGiene Insta-Warmth) 1x/day for 2 weeks in office | MGYLS LF: 3.6 (3.8) CL: 4.2 (3.9) | MGYLS LF: 19.7 (1.0)* CL: 16.2 (10.8) | OSDI LF: 55.0 (18.0) CL: 47.3 (18.1) | OSDI LF: 27.5 (18.1)*† CL: 34.2 (19.8)* | TBUT LF: 6.9 (4.3) CL: 26.3 (6.2) | TBUT LF: 8.4 (3.7)*† CL: 19.0 (9.9) | Corneal + Conjunct LF:2.5 (0.8) CL: 2.5 (0.9) | Corneal + Conjunct LF:2.1 (0.3)*† CL: 2.3 (0.7) | Both LF and CL were effective at treating MGD. However, LF Tx was more effective and achieved better 3 months long-term efficacy than CL AEs None. No change in IOP |
Blackie 2018 [34] Prospective, open-label, randomized, crossover, multicenter USA and Canada | N = 55 patients, contact lens wearer; LF: N = 29 patients (58 eyes), 40 (13) years CL: N = 26 patients (52 eyes), 44 (16) years; CO: N = 25 patients (50 eyes) in CL who were CO to LF | 3 months; CO: 1 month | Single 12-min LF Tx plus blinking exercises for 1 month post-Tx to foster healthy blinking habits CL: untreated | MGSS LF: 8.0 (3.5) CL: 8.2 (4.2) MGYLS LF: 1.9 (1.6) CL: 2.1 (1.7) | MGSS LF: 20.4 (9.1)† CL: 9.6 (5.7) CO: 22.4 (9.4)† MGYLS LF: 7.1 (3.6)† CL: 2.5 (2.2) CO: 7.9 (3.6)† | SPEED LF: 14.5 (4.8) CL: 15.3 (4.5) OSDI LF: 39.6 (16.4) CL: 40.8 (20.3) | SPEED LF: 6.1 (4.6)† CL: 14.5 (5.3) CO: 7.4 (5.0)† OSDI LF: 13.4 (15.5)† CL: 37.5 (23.8) CO: 13.8 (11.2)† | TBUT LF: 4.8 (2.7) CL: 4.6 (2.0) | TBUT LF: 6.5 (4.0)† CL: 4.3 (1.7) CO: 5.3 (2.4)† | Conjunct LF: 3.5 (3.0) CL: 4.3 (3.6) | Conjunct LF: 3.4 (3.3)† CL: 5.6 (4.5) CO: 3.6 (3.7) | LF Tx improved signs and symptoms of DED and increased mean comfortable contact wearing time by 4 h, approximately doubling the comfortable wearing time, and was sustained for 3 months AEs None related to LF. N = 11 AEs unrelated LF (N = 5 ocular, N = 6 systemic). Slit-lamp findings not considered AEs were observed immediately after LF: eyelid edema, conjunctival edema, conjunctival hyperemia/injection, petechiae, and SPK and were transient and did not require Tx |
Hagen 2018 [30] Prospective, randomized, parallel group, single-masked USA | N = 28 patients with moderate-to-severe MGD (50 eyes); LF: N = 14 patients (26 eyes), 52 (6) years; Doxy: N = 14 patients (24 eyes), 50 (14) years | 3 months | Single 12-min LF Tx Oral doxy daily for 3 months (100 mg BID for the first 14 days and 100 mg 1x/day for days 15–90) | MGYLS LF:4.0 (1.5) Doxy: 4.6 (1.4) | MGYLS LF: 7.7 (5.5)* Doxy:10.6 (6.0)* | SPEED LF: 11.0 (3.3) Doxy: 13.4 (4.2) | SPEED LF: 5.4 (2.2)*† Doxy: 9.4 (5.5)* | TBUT LF:6.3 (2.0) Doxy: 6.9 (2.6) | TBUT LF: 8.4 (1.8)* Doxy: 7.6 (2.0) | Corneal LF: 0.4 (0.5) Doxy: 0.2 (0.4) Conjunct LF: 1.7 (1.9) Doxy: 2.4 (1.9) | Corneal LF:0.1 (0.3)* Doxy: 0.1 (0.3) Conjunct LF: 0.6 (0.8)* Doxy: 1.1 (1.5)* | LF was significantly more effective than doxy at treating signs and symptoms of MGD and was a favorable alternative to doxy AEs LF: N = 0 Doxy: N = 2 (stomach upset/intolerance) |
Yeo 2016 [82] Singapore | N = 90 patients, LF: 24 patients (48 eyes) Hot towel: N = 22 patients (44 eyes), EyeGiene: N = 22 patients (44 eyes); Blephasteam: N = 22 patients (44 eyes) | 3 months | Single 12-min LF Tx Details of other Tx NR | NR | NR | NR | NR | NR | NR | NR | NR | LF Tx significantly reduced tear evaporation rate |
Finis 2014 [31] Prospective, randomized, crossover, observer-masked Germany This is a long-term FU of Finis 2014 [32] | N = 26 patients with MGD (52 eyes), 50 (22) years; LF: N = 17 patients (34 eyes), 45 (23) years; CL: N = 9 patients (18 eyes) with CL for 3 months prior to LF | 6 months post-LF | Single 12-min LF Tx CL: Lid warming BID and massage for 3 months | MGYLS LF: 2.9 (1.6) | MGYLS LF: 6.4 (4.6)* | OSDI LF: 42 (19) SPEED LF: 16 (7) CL: 15.9 (6.6) CO: 14.7 (7.7) | OSDI LF: 33 (21)* SPEED LF: 12 (7)* CL: 14.7 (7.1) CO: 12.6 (6.5) | TBUT LF: 9.5 (8.7) | TBUT LF: 10.0 (6.7) | Corneal + Conjunct LF: 2.0 (2.0) | Corneal + Conjunct LF: 2.4 (2.3) | LF reduces subjective symptoms and objective measures of MGD over 6 months but has no effect on atrophy of MG as visualized by meibography. Safety NR |
Finis 2014 [32] Prospective, randomized, crossover, observer-masked Germany | N = 31 patients with MGD; LF: N = 17 patients (34 eyes), 45 (23) years; CL: N = 14 patients, (28 eyes) 50 (19) years After completing the initial study, 9 CL patients (18 eyes) completed a 3-month CO with LF | 3 months | Single 12-min LF Tx CL: Lid warming BID and massage for 3 months | MGYLS LF: 2.5 (1.4) CL: 2.1 (1.3) CO: 4.1 (2.5) | MGYLS LF: 5.5 (3.6)* CL: 4.6 (3.8)* CO:5.8 (3.2) | OSDI LF: 46.2 (14.8) CL: 40.1 (16.7) CO: 39.7 (26.3) SPEED LF: 16.8 (5.6) CL: 15.9 (6.6) CO: 14.7 (7.7) | OSDI LF: 34.6 (19.6)* CL: 40.0 (23.4) CO: 32.8 (24.4) SPEED LF: 14.5 (7.2) CL: 14.7 (7.1) CO: 12.6 (6.5) | NIBUT LF: 7.9 (8.5) CL: 7.7 (6.1) CO: 6.7 (6.1) | NIBUT LF: 9.9 (7.0) CL: 7.5 (6.1) CO: 7.3 (5.1) | Corneal + Conjunct LF: 2.6 (2.4) CL:1.9 (2.4) CO: 1.4 (1.4) | Corneal + Conjunct LF: 3.5 (2.7) CL:1.1 (1.4) CO: 3.0 (2.2) | Single LF Tx was at least as effective as a 3-month BID lid margin hygiene regimen. Safety NR |
Baumann 2014 [35] Single-center, prospective, randomized France | N = 30 patients with moderate-to-severe DED and MGD; LF: N = 15 patients (30 eyes), 65 (12) years; CL: N = 15 patients (30 eyes), 65 (11) years | 3 months | Single 12-min LF Tx plus blinking exercises CL: MeiboPatch heat mask for 10 min and massage for 10 min 1x/day for 3 months plus blinking exercises | MGYLS LF: 3.3 (1.7) CL: 5.7 (3.2) | MGYLS LF: 8.5 (2.4)* CL: 9.4 (4.3)* | OSDI LF: 51.0 (20.8) CL: 42.9 (20.3) SPEED LF: 16.5 (4.6) CL: 13.5 (3.1) | OSDI LF: 27.0 (17.6)* CL: 23.5 (15.3)* SPEED LF: 8.0 (5.3)* CL: 8.9 (5.2)* | TBUT LF: 4.5 (2.3) CL: 5.2 (2.2) | TBUT LF: 6.8 (2.5)* CL: 6.9 (2.2)* | Corneal + conjunct LF: 1.0 (1.1) CL:1.8 (1.2) | Corneal + conjunct LF: 0.4 (0.8)* CL:0.7 (0.7)* | LF Tx is highly effective in treating MGD. The results for 3 months of CL Tx were excellent, but not convenient for the patient Randomized but MGD more severe in LF group at BL Safety NR |
Lane 2012 [14] Randomized, controlled, open-label, crossover, multicenter USA | N = 139 patients with MGD; LF: N = 69 patients (138 eyes), age NR; CL: N = 70 patients (140 eyes), age NR; CO: N = 68 patients (136 eyes) in CL group who were CO to LF | LF: 1 month; CL: 2 weeks; CO: 2 weeks | Single 12-min LF Tx CL: Warm compress (iHeat) for 5 min/day for 2 weeks | MGSS LF: 6.3 (3.5) CL: 5.6 (3.9) MGYLS LF: 0.6 (0.9) CL: 0.4 (0.8) | MGSS LF: 14.3 (8.7) at 2 weeks*†; 16.7 (8.7) at 1 month* CL: 6.1 (5.6) CO: 11.7 (7.3)† MGYLS LF: 2.0 (2.9) at 2 weeks*†; 2.6 (3.6) at 1 month* CL: 0.5 (1.1) CO: 1.2 (1.9)† | SPEED LF: 14.3 (4.8) CL: 14.8 (4.8) OSDI LF: 32.0 (20.0) CL: 34.7 (19.6) | SPEED LF: 8.1 (5.5) at 2 weeks*†; 7.6 (5.8) at 1 month * CL: 11.2 (5.4) CO: 7.9 (5.6)† OSDI LF: 17.3 (17.2) at 2 weeks*†; 16.6 (18.1) at 1 month * CL: 26.9 (18.2) CO: 21.0 (18.3)† | TBUT LF: 5.5 (2.9) CL: 5.4 (3.5) | TBUT LF: 6.9 (5.0) at 2 weeks*†; 7.4 (5.5) at 1 month * CL: 5.3 (3.5) CO: 6.3 (4.7)† | Corneal LF: 2.2 (2.2) Conjunct LF: 1.3 (2.1) | Corneal LF: 1.5 (1.7) at 1 month* Conjunct LF: 1.6 (2.5) at 1 month* | LF Tx improved signs and symptoms over 1 month The safety profile of LF Tx reflects a low occurrence of non-serious, transient side effects that resolve quickly and do not require medical treatment AEs LF: N = 4 (N = 3 eyelid pain, N = 1 conjunctival vascular injection) CL: N = 2 (burning) Mean discomfort score during LF Tx was 1.4 (scale 0–10). Slit-lamp findings not considered AEs most frequently were trace to mild conjunct injection, hyperemia, or redness; and trace or mild petechial hemorrhages on the eyelid or conjunct immediately or 1 day post-Tx, which fully resolved by the 2-week visit without Tx. No changes in the intraocular findings except for 1 case of posterior vitreous floaters unrelated to device |
Prospective, Controlled, Non-randomized Trials
Author/design/country | Patients (eyes)/age, mean (SD) | Last FU | Study arms | MG function Mean (SD) | Patient-reported outcomes Mean (SD) | NIKBUT/TBUT Mean (SD) | Staining | Overall conclusion and safety | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
Dierker 2022 [36] Single-center, open-label, prospective, non-randomized, subject-masked, sham-controlled USA | N = 20 patients with MGD, 59 (11) years; LF: 19 eyes, CL: 19 eyes | 3 months | Single 12-min LF Tx plus Dex intracanalicular insert CL: Single 12-min LF Tx plus sham punctal dilation | MGSS LF/Dex: 13.3 (8.1) LF/CL: 16.3 (8.0) | MGSS LF/Dex: 29.8*† (9.9) LF/CL: 27.3 (11.4)* | NR | NR | TBUT LF/Dex:3.2 (2.2) LF/CL: 4.1 (3.4) | TBUT LF/Dex: 6.1 (4.8)*† LF/CL: 4.7 (3.4) | Corneal + Conjunct LF/Dex: 6.6 (6.3) LF/CL: 5.2 (4.7) | Corneal + Conjunct LF/Dex: 5.7 (5.9) LF/CL: 6.2 (6.5) | Dex provides additional therapeutic benefit when combined with LF for improving signs of DED AEs None, IOP and VA remained stable in both groups |
Laufenböck 2022 [37] Prospective, non-masked, single-center Austria | N = 30 patients with DED and MGD, LF: 15 patients (30 eyes), 63 (7) years CL: 15 patients (30,eyes) 61 (6) years | 3 months | Single 12-min LF Tx plus hyaluronic acid eye drops 3x/day CL: Daily massage plus hyaluronic acid eye drops 3x/day | MGYLS (yes/no scale)1 LF:1.8 CL: 1.9 | MGYLS (yes/no scale)1 LF:1.4† CL: 1.75 | OSDI LF: 22.2 CL: 22.7 | OSDI LF: 14.2† CL: 18.5 | NIKBUT LF: 6.8 CL: 6.7 | NIKBUT LF: 11.2† CL: 8.3 | NR | NR | Both Tx improved measures of MGD but more strongly in the LF group. AEs NR. Safety parameters (IOP and VA) were normal in all patients |
Zhao 2016 [38] Prospective, examiner-masked, contralateral eye (worst eye treated) China | N = 29 Chinese patients with MGD (58 eyes), 57 (7) years; LF: 29 patients (29 eyes); CL: 29 patients (29 eyes) | 3 months | Single 12-min LF Tx CL: untreated | MGYLS LF: 1.78 (1.8) CL: 2.34 (1.9) | MGYLS LF: 4.75 (3.1)*† CL: xx2 | SPEED LF: 11.2 (4.9) CL: xx2 | SPEED LF: 4.6 (3.4)* CL: xx2 | TBUT LF: 2.5 (0.8) CL: 2.8 (1.0) | TBUT LF: 3.5 (1.4)*† CL: xx1 | Corneal LF: 2.3 (1.8) CL: 1.6 (0.7) | Corneal LF: 1.3 (1.5)* CL: xx2 | LF significantly improved objective measures of MGD compared with the contralateral eye. Safety NR |
Open-Label Studies
Author/design/country | Patients (eyes)/age, mean (SD) | Last FU | Study arms | MG function Mean (SD) | Patient-reported outcomes Mean (SD) | NIKBUT/TBUT Mean (SD) | Staining | Overall conclusion and safety | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
Liu 2023 [39] Prospective interventional China | N = 50 patients with MGD, LF: N = 25 patients (50 eyes), 36 (10) years; CL: N = 25 patients (50 eyes), 35 (6) years | 3 months | Single 12-min LF Tx CL: warm eyelid with spontaneous steam eyelid masks for 20 min and massage for 15 min, 1x/day for 3 months | NR | MGE change from BL LF: − 0.46 (0.58)* CL: − 0.40 (0.49) MGSS change from BL LF: − 5.44 (3.23)* CL: − 3.28 (3.37) | NR | OSDI change from BL LF: − 17.4 (20.3)†* CL: -8.8 (13.5) | NR | NIKBUT change from BL LF:1.46 (2.18)* CL: 1.07 (2.33) TBUT change from BL LF:1.91 (0.87) CL: 1.49 (1.71) | NR | Corneal change from BL LF: − 0.52 (0.84)†* CL: − 0.18 (0.66) | LF improved MGD and was well tolerated AEs LF: N = 1 patient (slight irritation) CL: N = 10 patients (mild to severe pain/ discomfort). LF was significantly more comfortable than CL. No loss of VA or IOP > 21 mmHg |
Novo-Diez 2022 [40] Prospective, single-center, open-label Spain | N = 21 patients with MGD exposed to adverse environmental humidity (42 eyes), 60 (9) years | 12 months | Single 12-min LF Tx | MGYLS LF: 10.3 (1.5) | MGYLS LF: 12.2 (2.2)* | OSDI LF: 43.0 (23.9) | OSDI LF: 29.0 (22.2)* | TBUT LF: 4.2 (4.1) | TBUT LF: 4.3 (5.2) | Conjunct LF: 2 (2) | Conjunct LF: 0 (0)* | LF improves objective and subjective measures of MGD and the effects are sustained for ≥ 1 year AEs None. No significant changes in VA |
Hu 2022 [19] Prospective, open-label, multicenter USA | N = 44 patients with MGD (88 eyes), 67 (8) years | Post-LF | Single 12-min LF Tx | – | – | – | – | – | – | Corneal LF: 3.1 (1.9) Conjunct LF: 3.4 (2.3) | Corneal LF: 3.9 (2.3)* Conjunct LF: 4.3 (2.9)* Note: the differences were considered statistically but not clinically significant | The LF Activator Clear enables efficient and confident positioning around the eyelids to ensure successful LF Tx when used as indicated AEs None. No safety-related concerns |
Fallah 2021 [41] Prospective, open-label USA | N = 96 patients with MGD (192 eyes), age NR | 3 months | Single 12-min LF Tx | NR | NR | OSDI LF: 35.7 | OSDI LF: 30.1* | NR | NR | NR | NR | Significant improvement in subjective symptoms, but smaller than reported in previous studies AEs None |
Chan 2021 [42] Prospective, observational Hong Kong | N = 16 patients with MGD (30 eyes), mean age NR | 1 month | Single 12-min LF Tx | NR | NR | SPEED II LF: 12.9 (1.3) | SPEED II LF: 8.7 (0.7)* | NR | NR | NR | NR | LF Tx was effective in improving both objective and subjective measures of MGD. Safety NR |
Li 2020 [43] Prospective, interventional China | N = 50 patients (50 eyes); N = 25 patients with OMGD (25 eyes), 37 (12) years; N = 25 patients with HMGD (25 eyes), 33 (10) years | 3 months | Single 12-min LF Tx | MGSS LF/OMGD: xx1 MGE LF/OMGD: xx1 | MGSS LF/OMGD: xx1* MGE LF/OMGD: xx1* | SPEED LF/OMDG: 12.0 (2.5) LF/HMGD: 12.1 (2.5) OSDI LF/OMDG: 22.9 (4.4) LF/HMGD: 24.1 (4.8) | SPEED LF/OMDG: 1.5 (1.3)*† LF/HMGD: 5.2 (2.0)* OSDI LF/OMDG: 1.7 (0.8)*† LF/HMGD: 12.9 (4.1)* | NIKBUT LF/OMDG: 3.2 (1.5) LF/HMGD: 3.2 (1.4) | NIKBUT LF/OMDG: 4.4 (1.4)*† LF/HMGD: 3.0 (1.1) | NR | NR | LF Tx was effective for OMGD and HMGD. It is more effective for OMGD. Safety NR |
Godin 2018 [44] Prospective USA | N = 13 patients with Sjögren's disease (24 eyes), 62 years | 1 year | Single 12-min LF Tx | NR | NR | OSDI LF: 40.4 | OSDI LF: 47.6 | TBUT LF: 3.8 | TBUT LF: 7.5* | Corneal LF: 1.0 Conjunct LF: 1.5 | Corneal LF: 0.48* Conjunct LF: 0.48* | LF Tx improved signs of DED and MGD in patients with symptomatic Sjögren's disease on maximum therapy. Safety NR |
Zhao 2016 [50] Single-center, controlled, open-label Singapore | N = 46 patients with MG dropout; LF: N = 24 patients (24 eyes), 56 (13) years; CL: N = 22 patients (22 eyes), 56 (11) years | 3 months | Single 12-min LF Tx plus daily manual lid massage and lid cleaning for 3 months CL: warm compress with towel 10 min/day BID plus daily manual lid massage and lid cleaning for 3 months | MGYLS LF: xx1 | MGYLS LF: xx1* | SANDE LF: 45.6 (25.2) CL:52.4 (20.4) | SANDE % change from BL LF: − 30.5 (P < 0.05 vs. BL at 1 month but not 3 months) CL: − 15.9 (P < 0.05 vs. BL at 1 month but not 3 months) | TBUT LF: 2.4 (1.1) CL: 2.4 (1.3) | TBUT % change from BL LF: 89.2 (P < 0.05 vs. BL at 1 month but not 3 months) CL:63.0 | NR | NR | In Asian patients, LF improved symptoms of MGD, and 1 session of LF was comparable to 3 months of BID lid warming, massage, and hygiene All LF Tx patients had transient eye redness and mild eyelid puffiness for a few min after Tx. No other AEs |
Greiner 2016 [45] Prospective, observational, single-center USA | N = 20 patients with DED and MGD (40 eyes), 61 (11) years | 3 years | Single 12-min LF Tx | MGSS LF: 4.5 MGYLS LF: 13.7% of glands studied | MGSS LF: 18.4* MGYLS LF: 53.7% of glands studied | SPEED LF: 13.4 OSDI LF: 26.0 | SPEED LF: 9.5 (1.6)* OSDI LF: 22.5 (5.4) (P < 0.05 vs. BL at 1, 9 months, and 1 year but not 3 years) | TBUT LF: 4.1 (0.4) | TBUT LF: 4.5 (0.6) (P < 0.05 vs. BL at 1 month and 9 months but not 3 years) | Corneal LF: 0.4 (0.3) Conjunct LF:0.01 (0.03) | Corneal LF: 0.9 (0.6) Conjunct LF:0.8 (0.5) | The study reinforces the potential long-term (3 years) benefits of a single LF Tx. Safety NR |
Blackie 2016 [11] Prospective, multicenter, open-label USA | N = 200 patients with MGD and evaporative dry eye (400 eyes); 56 (15) years; LF: 101 patients (202 eyes); CL: N = 99 patients (198 eyes); CO: N = 93 patients (186 eyes) in CL who were CO to LF | 12 months (9 months for CO group) | Single 12-min LF Tx CL: warm compress with EyeGiene InstaWarmth and lid hygiene with OCuSOFT Lid Scrub Original 10 min/day BID for 3 months | MGSS LF: 6.2 (3.7) CL: 6.3 (3.7) | MGSS LF: 17.3 (9.1)* CL: 11.0 (at 3 months) CO: 18.4 (11.1)* | OSDI LF: 45.6 (21.2) CL: 51.8 (23.1) | OSDI LF: 21.6 (21.3)* CL: 31.3 (at 3 months) CO: 24.0 (23.2)* | NR | NR | NR | NR | LF Tx has sustained improvement in MG function and symptoms over 12 months AEs LF: N = 10 (N = 3 eye/eyelid discomfort/pain most common, others NR); CL: N = 8 (N = 3 eyelid skin dermatitis most common, others NR). All AEs transient, nonserious, and resolved with no Tx |
Satjawatcharaphong 2015 [51] Open-label USA | N = 32 patients with DED and MGD (64 eyes), 54 (15) years | Mean 52 days (range: 21–84 days) | Single 12-min LF Tx plus warm compress, massage, and eyelid hygiene were recommended BID until FU | MGSS LF: 17.3 (12.9) | MGSS LF: 29.0 (12.6)* | SPEED LF: 15.7 (5.5) | SPEED LF: 12.9 (5.7)* | NIKBUT LF: 6.1 (3.2) | NIKBUT LF: 7.6 (2.6) | Corneal LF: 1.8 (3.8) Conjunct LF: 1.4 (2.1) | Corneal LF: 2.8 (6.6) Conjunct LF: 2.8 (6.6) | Results identified factors that better select candidates for LF Tx (At BL: men, higher inferior conjunctival staining, greater number of unexpressible glands) AEs NR Bulbar redness after at-home therapy (N = NR) |
Greiner 2013 [46] Prospective, single-center, observational, open-label USA | N = 18 patients with MGD and evaporative DED (36 eyes), 63 (12) years Note: This is a subgroup, long-term FU from Lane 2012 [14] | 12 months | Single 12-min LF Tx | MGSS LF: 4.0 (3.4) | MGSS LF: 7.3 (4.6)* | SPEED 12.9 (3.8) OSDI LF: 22.2 (14.2) | SPEED 6.3 (5.5)* OSDI LF: 12.4 (14.6)* | TBUT LF: 4.9 (3.0) | TBUT LF: 6.0 (4.4) | NR | NR | LF Tx-induced improvement is sustained for up to 1 year. Safety NR |
Korb 2013 [47] Case report USA | N = 1 patient (2 eyes) with NOMGD with significant MG dropout and truncation | 7 months | Single 12-min LF Tx | MGYLS LF OD: 1 LF OS: 1 | MGYLS LF OD: 4 LF OS: 4 | SPEED LF OD: 24.0 LF OS: 28.0 | SPEED LF OD: 6.0 LF OS: 6.0 | TBUT LF OD: 4 LF OS: 4 | TBUT LF OD: 7 LF OS: 9 | NR | NR | LF Tx was effective in a patient with significant gland dropout and truncation, and glands were restored to functional health for ≥ 7 months AEs None, no discomfort |
Greiner 2012 [48] Prospective, open-label USA | N = 21 patients with MGD and dry eye (42 eyes), 62 years | 9 months | Single 12-min LF Tx | MGSS LF: 4.4 (4.0) | MGSS LF: 11.7 (5.9)* | SPEED LF: 12.9 (4.0) OSDI LF: 23.4 (14.4) | SPEED LF: 6.2 (4.0)* OSDI LF: 12.4 (15.3)* | TBUT LF: 9.6 (7.6) | TBUT LF: 7.1 (5.6)* | NR | NR | LF Tx improved signs and symptoms of DED and was maintained for 9 months. Safety NR |
Friedland 2011 [49] Multicenter, open-label feasibility USA | N = 14 patients with moderate-to-severe dry eye and MGD, 54 (10) years; LF: N = 14 eyes; CL: N = 14 eyes | 3 months | Single 12-min LF Tx CL: Single 12-min LF Tx plus heat and pressure with a handheld device (type NR) with MGX to assess whether all material was removed | MGSS LF: 3.4 (3.2) CL: 2.5 (2.3) MGYLS LF: 2.9 (2.8) CL: 2.1 (2.4) | MGSS LF: 9.9 (3.2)* CL: 9.2 (4.3)* MGYLS LF: 9.9 (3.1)* CL: 10.5 (4.9)* | SPEED LF: 16.2 (5.4) CL: 16.2 (5.4) OSDI LF: 37.0 (23.8) CL: 37.9 (21.4) | SPEED LF: 7.8 (4.8)* CL: 7.8 (4.8)* OSDI LF: 18.3 (14.0)* CL: 24.5 (26.5)* | TBUT LF: 5.2 (2.6) CL: 5.8 (3.4) | TBUT LF: 11.0 (6.3)* CL:11.8 (5.9)* | Corneal LF: 0.6 (0.8) CL:0.6 (0.7) | Corneal LF: 0.1 (0.3)* CL: 0.1 (0.3)* | LF Tx was highly effective at improving signs and symptoms of MGD and DED for 3 months AEs N = 3 (discomfort, chalazion unrelated to Tx, internal hordeola unrelated to Tx) |
Korb 2010 [13] Case report USA | N = 1 patient with NOMGD (2 eyes) | 3 months | Single 12-min LF Tx | MGYLS LF OD: 0 LF OS: 1 | MGYLS LF OD: 6 LF OS: 6 | SPEED LF OD: 20.0 LF OS: 19.0 OSDI LF OD: 70.8 LF OS: 66.7 | SPEED LF OD: 3.0 LF OS: 4.0 OSDI LF OD: 18.8 LF OS: 14.6 | TBUT LF OD: 5.2 LF OS: 4.5 | TBUT LF OD: 10.7 LF OS: 13.8 | NR | NR | LF Tx was effective at treating NOMGD for at least 3 months AEs None, no significant discomfort Note: this is the first published report of the use of LF |
Retrospective Studies
Author/design/country | Patients (eyes)/age, mean (SD) | Last FU | Study arms | MG function, mean (SD) | Patient-reported outcomes Mean (SD) | NITBUT/TBUT, mean (SD) | Staining | Overall conclusion and safety | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
Chung 2022 [56] Retrospective South Korea | N = 23 patients with refractory MGD (23 eyes), 42 (13) years | 12 months | 12-min LF Tx plus IPL plus MGX all 3 times (once every 3 weeks); followed by IPL plus MGX monthly through 18 weeks; followed by MGX, monthly through 12 months | MGE Grade Score BL: 2.6 (0.6) Note: graded 0–3 | MGE Grade Score 1.2 (0.6)* | OSDI BL: 49.0 (14.9) | OSDI 15.5 (8.7)* | NIBUT BL: 3.2 (1.2) | NIBUT 8.0 (1.9)* | NR | NR | LF combination Tx was effective and safe for treating refractory MGD with prolonged effects maintained with monthly MGX AEs N = 3 (gritty sensation with mild discharge for 1 day). No sign changes in VA |
Kim 2020 [57] Retrospective South Korea | N = 30 patients with obstructive MGD (60 eyes); LF: 15 patients (30 eyes); 40 (7) years CL: 15 patients (30 eyes), 39 (11) years | 6 months | 12-min LF Tx 3 times (1x/month for 3 months) CL: Single 12-min LF Tx followed by MGX 3 times (1x/month for 3 months) All eyes had artificial tears containing 0.1% hyaluronic acid (Haylene) 3 × or 4x/day for 6 months | NR | NR | OSDI LF: 43.6 (10.4) CL: 51.3 (15.5) | OSDI LF: 33.3 (13.2)* CL: 13.1 (6.9)*† | NIBUT LF: NR1 CL: 3.2 (1.2) | NIBUT LF: NR1 CL: 8.5 (1.5)*† | NR | NR | Both LF only and MGX after LF were clinically effective for obstructive MGD. Efficacy and persistence were greater in the MGX plus LF group AEs None |
Hura 2020 [52] Retrospective, single masked USA | N = 43 patients with DED and MGD (70 eyes); LF: N = 30 patients (48 eyes), age NR; CL: N = 13 patients (22 eyes), age NR | 12 months | Single 12-min LF Tx CL: untreated but LF recommended | MGSS LF: 5 CL: 7 | MGSS LF: 12*† CL: 6 | SPEED LF: 15 CL:12 | SPEED LF: 10 CL: 9 | TBUT LF: 3 CL: 4 | TBUT LF: 7*† CL: 3 | Corneal LF: 0.44 CL: 0.39 Note: score 1 = presence and 0 = absence | Corneal LF: 0 31*† CL: 0.67 | Compared with CL, MG structure may increase post-LF Tx suggesting restored acini activity. Safety NR |
Arita 2021 [58] Retrospective, randomized Japan | N = 165 patients with MGD (165 eyes); LF: 30 patients/eyes, 63 (14) years; CL 1: 30 patients/eyes, 59 (19) years; CL 2: 30 patients/eyes, 59 (15) years; CL 3: 38 patients/eyes, 60 (16) years; CL 4: 37 patients/eyes, 61 (18) years | 1 month | Single 12-min LF Tx plus warm compress and lid hygiene BID for 1 month CL1: warm compress and lid hygiene BID for 3 months CL 2: Artia MG compressor every 3 weeks for 4 times plus warm compress and lid hygiene BID for 3 months CL 3:Azithromycin eyedrops plus warm compress and lid hygiene BID for 2 weeks CL 4: IPL (M22) every 3 weeks for 4 sessions plus warm compress and lid hygiene BID for 3 months | MGE Grade Score LF: 2.3 (0.4) CL 1: 2.3 (0.5) CL 2: 2.4 (0.5) CL 3: 2.3 (0.4) CL 4: 2.6 (0.5) Note: graded 0–3 | MGE Grade Score LF: 1.7 (1.0)* CL 1: 1.8 (0.9)* CL 2: 1.6 (0.9)* CL 3: 1.2 (0.8)* CL 4: 0.1 (0.4)* | SPEED LF:11.3 (3) CL 1: 12.2 (3.9) CL 2: 12.5 (4.2) CL 3: 12.6 (4) CL 4: 13.4 (3.2) | SPEED LF: 8.7 (4.2)* CL 1: 9.0 (3.6)* CL 2: 8.9 (4.9)* CL 3: 6.2 (4.5)* CL 4: 3.7 (2.8)* | TBUT LF: 3.3 (0.7) CL 1: 3.1 (1.2) CL 2: 3.0 (1.1) CL 3: 3.2 (1.0) CL 4: 3.1 (1.2) | TBUT LF: 3.1 (1.7)* CL 1: 3.4 (1.3)* CL 2: 3.9 (0.6)* CL 3: 5.8 (2.8) CL 4: 6.7 (2.4)* | Corneal + Conjunct LF: 0.9 (0.6) CL 1: 0.8 (0.6) CL 2: 0.8 (0.8) CL 3: 1.0 (1.2) CL 4: 1.0 (1.1) Note: Score 0–9 | Cornea + Conjunct LF: 0.8 (0.6)* CL 1: 0.6 (0.6)* CL 2: 0.5 (0.7)* CL 3: 0.4 (1.0)* CL 4: 0.1 (0.3)* | When MG loss is early and mild or moderate, several Tx options are available. When MG loss is severe, IPL is recommended. Safety NR |
Kim 2017 [53] Retrospective chart review USA | N = 98 patients with MGD and DED (189 eyes), 60 years | Mean 77 days | Single 12-min LF Tx | NR | NR | OSDI LF: 50.5 (25.1) | OSDI LF: 41.4 (26.4)* | TBUT LF: 4.5 (1.4) | TBUT LF: 8.5 (1.7)* | NR | NR | LF Tx improves subjective and objective measures of DED. Safety NR |
Gibbons 2017 [59] Retrospective interventional case series USA | N = 49 patients with symptomatic MGD (98 eyes); N = 32 patients who responded to Tx, 63 (15) years; N = 17 patients with no response to Tx, 62 (16) years | 3–4 months | Single 12-min LF Tx followed by 10 min heat (gel mask), lid hygiene, and MGX every 4–6 weeks for 3 times | MGE Grade Score LF responded to Tx: 5.9 (1.9) LF no response to Tx: 5.6 (1.9) Note: grading not defined | MGE Grade Score NR | OSDI LF responded to Tx: 54.0 (24.3) LF no response to Tx: 57.6 (19.9) | OSDI NR | TBUT LF responded to Tx: 4.1 (3.0) LF no response to Tx: 4.6 (3.5) | TBUT NR | Corneal LF responded to Tx: 4.4 (5.0) LF no response to Tx: 0.4 (1.1) Conjunct LF responded to Tx: 3.1 (2.4) LF no response to Tx: 1.5 (1.8) | Corneal NR† Conjunct NR† | Patients with signs of lower tear production, higher corneal and conjunct staining scores, and higher osmolarity tend to respond better to LF AEs None |
Epitropoulos 2017 [54] Retrospective USA | N = 59 patients with MGD (102 eyes), 62 (14) years; LF SS+: N = 23 patients (43 eyes); LF SS-: N = 36 patients (59 eyes) | 2 months | Single 12-min LF Tx | MGSS LF SS +: 2.1 LF SS-: 2.4 | MGSS LF SS+: 13.0* LF SS-: 15.9*† | SPEED LF SS+: 17.9 LF SS-: 15.9 | SPEED LF SS+: 12.5* LF SS-: 10.1* | TBUT LF SS+: 3.7 LF SS-: 3.8 | TBUT LF SS+: 9.6* LF SS-: 8.3* | NR | NR | LF Tx in patients SS+ and with MGD had significant improvement in signs and symptoms of dry eye. Improvement in MGS scores were > in SS- patients. Safety NR |
Liang 2015 [55] Retrospective case series China | N = 48 patients with MGD (96 eyes) | 3 months | Single 12-min LF Tx | MGSS LF: 6.2 (2.5) MGYLS LF: 2.9 (1.1) | MGSS LF: 12.7 (3.4)* MGYLS LF: 5.2 (2.1)* | OSDI LF: 45.4 (19.3) | OSDI LF: 25.7 (14.1)* | TBUT LF: 4.7 (2.3) | TBUT LF: 9.9 (3.0)* | Corneal + Conjunct LF: 2.4 (2.2) | Corneal + Conjunct LF: 2.1 (1.1) | LF is an effective and safe Tx for MGD AEs None No discomfort /pain, tearing, or irritation 1 day post Tx. No sign changes in VA or IOP |
Safety in MGD Populations
Cataract
Author/design/country | Patients (eyes)/age, mean (SD) | Last FU after LF Tx | Study arms | MG function Mean (SD) | Patient-reported symptoms Mean (SD) | TBUT Mean (SD) | Staining | Overall conclusion and safety | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
Cataract | ||||||||||||
Schlatter 2023 [63] Prospective, randomized, controlled, investigator-masked | N = 31 patients with MGD and cataract (62 eyes), 44 (16) years; LF: N = 29 eyes; CL: N = 29 eyes | 3 months preop | Single 12-min LF Tx before cataract surgery CL: untreated | MGSS LF: 9.5 (5.2) CL: 9.9 (4.9) | MGSS LF: 14.4 (9.1)* CL: 13.6 (10.5) | NR | NR | TBUT LF: 5.6 (2.7) CL: 4.9 (2.1) | TBUT LF: 8.8 (4.4)* CL: 7.8 (4.4)* | NR | NR | Tear film parameters improved in LF eyes, but effect on spherical IOL selection was negligible AEs N = 1 (stye unrelated to LF) |
Mencucci 2023 [66] Prospective, unmasked, randomized controlled Italy | N = 46 patients with cataract and mild/moderate MGD (46 eyes), LF: N = 23 patients (23 eyes), 73 (8) years CL: N = 23 patients (23 eyes), 75 (8) years | 1 month (pre-cataract surgery) 2 months (= 1 month post-cataract surgery) | Single 12-min LF Tx CL: warm compress, massage BID for 1 month | MGYLS LF: 7.3 (0.8) CL: 7.7 (0.6) MGSS LF: 0.65 (0.77) CL: 0.33 (0.56) | MGYLS 1 month (preop): LF: 7.8 (0.51)* CL: 7.8 (0.4) 2 months (postop): LF: 7.9 (0.3)*† CL: 7.5 (0.7) MGSS 1 month (preop): LF: 0.21 (0.52)* CL: 0.21 (0.41) 2 months (postop): LF: 0.13 (0.34)*† CL: 0.54 (0.60) | SPEED LF: 6.1 (2.8) CL: 5.8 (1.5) | SPEED 1 month (preop): LF: 3.9 (2.2)*† CL: 5.1 (1.5) 2 months (postop): LF: 4.0 (1.8)*† CL: 6.0 (1.2) | NIKBUT LF: 5.2 (1.3) CL: 5.7 (1.2) | NIKBUT 1 month (preop): LF: 6.2 (1.7)* CL: 6.0 (1.2) 2 months (postop): LF: 6.3 (1.9)*† CL: 5.1 (1.5) | Corneal LF: 0.26 (0.44) CL: 0.13 (0.33) | Corneal 1 month (preop): LF: 0.13 (0.33) CL: 0.13 (0.33) 2 months (postop): LF: 0.13 (0.34) CL: 0.13 (0.33) | Preop LF Tx prevented postcataract surgery DED in patients with mild-to-moderate MGD. LF-treated patients had a better ocular surface status than CL AEs None No pain or discomfort |
Matossian 2023 [67] Prospective, randomized, open-label, crossover, multicenter USA | N = 121 patients with mild-to-moderate MGD and cataract; LF: N = 117 eyes, 65 (8) years; CL: N = 115 eyes, 65 (8) years | 3 months (3 months post-cataract surgery) CO: 1 month (4 months post-cataract surgery) | Single 12-min LF Tx CL: untreated | NR | MGSS: Change from BL to 3 months (postop): LF: 7.3 (9.3)† CL: 4.7 (10.1) MGYLS Change from BL to 1 month postop: LF: 1.6 (3.1) CL: 1.1 (3.3) CO MGSS: Change from 3 to 4 months postop: LF: 4.1 (11.0)† | NR | SPEED: Change from BL to 3 months: LF: -2.1 (5.3) CL:-1.5 (5.6) CO SPEED: Change from 3 to 4 months postop: LF: − 1.2 (5.6) | NR | TBUT Change from BL to 1 month postop: LF: 0.69 (4.6) CL: 0.06 (3.7) | NR | Corneal Change from BL to 1 month postop: LF: − 0.57 (2.3)† CL: 0.20 (3.2) Conjunct Change from BL to 1 month postop: LF: − 1.2 (3.8)† CL: 0.45 (4.0) | Presurgical LF Tx of patients implanted with range-of-vision IOLs improved MG function and postop ocular surface health. LF Tx reduced postop halos and improved VA AEs None related to LF, all related to cataract surgery |
Park 2021 [69] Prospective, randomized controlled study Korea | N = 124 patients with cataract (MGD was not a requirement) (124 eyes); LF: N = 60 patients (60 eyes), 64 (9) years CL: N = 48 patients (48 eyes), 65 (12) years | 3 months postop | Single 12-min LF Tx CL: untreated | MGSS LF: 1.0 (0.9) CL: 0.9 (0.8) MGYLS LF: 6.0 (2.1) CL:6.6 (2.1) | MGSS LF: 0.9 (0.9)*† CL: 1.7 (0.8)* MGYLS LF: 7.1 (1.7)*† CL: 5.6 (2.6)* | OSDI LF: 37.9 (20.2) CL: 34.3 (20.1) | OSDI LF: 22.3 (16.5)*† CL: 29.8 (20.8) | TBUT LF: 3.5 (1.5) CL: 3.7 (1.5) | TBUT LF: 4.4 (1.8)*† CL: 3.6 (1.6) | Corneal LF:0.77 (0.90) CL: 0.68 (0.92) | Corneal LF: 0.46 (0.56)* CL: 0.62 (0.56) | LF Tx conducted prior to cataract surgery may be safe and effective for relieving MGD and dry eye induced by surgery AEs None. No pain at insertion, treatment, or removal |
Zhao Y 2021 [68] Prospective, examiner-masked controlled, contralateral eye China | N = 32 patients with MGD and cataract (64 eyes); N = 16 patients undergoing cataract surgery, LF: N = 16 eyes, CL: N = 16 eyes, 62 (10) years; N = 16 patients no surgery (control), LF: N = 16 eyes, CL: N = 16 eyes, 62 (2) years In both groups LF in 1 eye and untreated contralateral eye | 3 months | Single 12-min LF Tx CL: untreated | MGYLS LF/surgery: 2.1 (1.8) CL/surgery: 1.9 (1.8) LF/non-surgery: 1.8 (1.8) CL/non-surgery: 2.6 (2.5) | MGYLS median change from BL: LF/surgery: 4.0* CL/surgery: − 2.0 LF/non-surgery: 3.0* CL/non-surgery: 0.0 (P < 0.05 vs. CL/surgery) | SPEED xx1 | SPEED xx1 | TBUT LF/surgery: 5.0 (2.3) CL/surgery: 4.9 (2.6) LF/non-surgery: 2.5 (0.6) CL/non-surgery: 2.8 (1.1) | TBUT median change from BL: LF/surgery: − 2.5 CL/surgery: − 2.0 LF/non-surgery: 1.0 (P < 0.05 vs. LF/surgery) CL/non-surgery: 0.0 (P < 0.05 vs. CL/surgery) | Corneal LF/surgery: 3.1 (0.4) CL/surgery: 3.2 (0.5) LF/non-surgery: 2.0 (0.5) CL/non-surgery: 1.9 (0.8) | Corneal xx1 | LF Tx before cataract surgery is effective in diminishing the blockage of MG and preventing a decline of TBUT after cataract surgery. Safety NR |
Szabelska 2023 [64] Open-label case series Poland | N = 6 patients with MGD and cataract (11 eyes), 67 years | 6 weeks | Single 12-min LF Tx 6 weeks pre-cataract surgery | NR | NR | OSDI LF: 31.1 | OSDI LF: 22.7 | TBUT LF: 9.1 | TBUT LF: 13.9 | NR | NR | Stabilization of visual system parameters after LF improved accuracy of IOL power recommendation. Safety NR |
Matossian 2020 [65] Single-center, pilot, retrospective USA | N = 23 patients with MGD and cataract (25 eyes), 73 (8) years | 6 weeks | Single 12-min LF Tx 6 weeks pre- cataract surgery | NR | NR | NR | NR | NR | NR | NR | NR | LF Tx resulted in less residual refractive astigmatism compared with pre-LF keratometry readings, which altered astigmatism management/ IOL selection. Safety NR |
Glaucoma | ||||||||||||
Kasetsuwan 2020 [70] Prospective, randomized, observer-blind Thailand | N = 60 patients with well-controlled glaucoma and MGD; LF: N = 26 patients (26 eyes), 67 (11) years; CL: N = 22 patients (22 eyes), 70 (8) years | 6 months | Single 12-min LF Tx plus lid hygiene CL: lid hygiene: warm compress, massage, baby shampoo, BID for 6 months | MGSS LF: 21.5 (5.8) CL: 22.5 (5.9) | MGSS change from BL: LF: 4.7* CL: 3.0* | OSDI LF: 23.7 (11.8) CL: 26.8 (18.2) | OSDI change from BL: LF: − 7.8* CL: -11.8* | TBUT LF: 5.4 (3.7) CL: 6.0 (5.4) | TBUT Change from BL: LF: − 0.30 CL:-0.58 | Corneal LF: 1.3 (0.8) CL: 1.0 (0.6) | Corneal Change from BL: LF: 0 CL: 0 | Adding LF Tx to lid hygiene significantly improved MG function and symptoms at 6 months AEs LF: N = 7 patients (N = 1 difficulty inserting the device, N = 5 mild discomfort immediately after Tx, N = 1 mild conjunctival injection CL: N = NR discomfort during massage. No IOP elevation or uncontrolled IOP that required additional antiglaucoma Tx |
Glaucoma
Refractive Surgery
Author/design/country | Patients (eyes)/mean age (SD) | Last FU | Study arms | MG function Mean (SD) | Patient-reported outcomes Mean (SD) | NITBUT/TBUT Mean (SD) | Staining | Overall conclusion and safety | ||||
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Pre | Post | Pre | Post | Pre | Post | Pre | Post | |||||
Shetty 2023 [71] Prospective interventional India | N = 59 patients with mild-to-moderate evaporative DED and/or MGD undergoing refractive surgery, LF pre-LASIK: N = 32 patients (64 eyes), 28 (5) years; LF post-LASIK: N = 27 patients (52 eyes), 27 (5) years | 3 months | Single 12-min LF Tx pre-LASIK CL: Single 12-min LF Tx 3 months post-LASIK | NR | NR | OSDI LF pre-LASIK group preop: 18.0 (2.2) LF post-LASIK group preop: 4.5 (0.9) | OSDI LF pre-LASIK group postop: 9.5 (1.6)* LF post-LASIK group pre-LF postop: 35.2 (2.3)* LF post-LASIK group post-LF & postop: 17.4 (2.6)*† | TBUT LF pre-LASIK group preop: 6.9 (0.2) LF post-LASIK group preop: 8.0 (0.1) | TBUT LF pre-LASIK group postop: 8.3 (0.2)* LF post-LASIK group pre-LF postop: 7.0 (1.5)* LF post-LASIK group post-LF & postop: 9.4 (0.2)*† | NR | NR | LF Tx prior to refractive surgery can help lessen the clinical effects of dry eyes after refractive surgery. Safety NR |
Schallhorn 2017 [72] Retrospective United Kingdom | N = 57 patients with dry eye post-LASIK or PRK (109 eyes), 49 years | Various: FU reported under each outcome | Single 12-min LF Tx Note: LF Tx mean 40.5 months after LASIK/PRK | MGD Grade Score NR Note: graded 0–4 | MGD Grade Score LF: Change from BL: − 0.69* Note: BL is pre-LF but post-LASIK/PRK | SPEED II LF: 17.5 | SPEED II LF: 10.2* Note: FU mean 25 days | TBUT LF: 3.7 Note: value pre-LF but post-LASIK/PRK | TBUT LF: 5.75* Note: FU mean 89 days | Corneal NR | Corneal LF: change from BL -0.74* Note: BL is pre-LF but post-LASIK/PRK | LF Tx may have utility in managing dry eye symptoms following laser vision correction. Safety NR |
Petzold 2016 [73] Case report Germany | N = 1 patient (2 eyes) 4 years post-LASIK with severe dry eye | 18 months | Single 12-min LF Tx | MGYLS LF OD: 8 LF OS: 10 | MGYLS LF OD: 12 LF OS: 13 | SPEED LF: 20 | SPEED LF: 12 | TBUT LF OD: < 5 LF OS: < 5 | TBUT LF OD: 8 LF OS: 14 | Corneal LF OD: 2–3 LF OS: 1 | Corneal LF OD: 0 LF OS: 0 | LF Tx successfully treated a case of post-LASIK dry eye that was refractory to conventional treatment. Safety NR |