Subjects
Forty-two eyes of 28 patients were prospectively examined; patients were further classified according to the orientation of the LRIs into 2 groups; group-A who had LRIs performed along the vertical meridian (vertical LRIs) and Group-B who had the LRIs performed along the horizontal meridian (horizontal LRIs). Inclusion criteria for the current study were: patients of both genders palnned to undergo cataract surgery with preoperatively documented mild to moderate corneal astigmatism (0.50–1.75 D) excluding those with severe corneal astigmatism (> 1.75 D) whom planned to have toric IOL implantation for correcting the pre-existing corneal astigmatism or not preferring to have the LRI procedure, patients with evident dry eye syndrome, severe ocular surface disorders, or systemic disease compromising the quality of the ocular surface (Steven-Johnson syndrome, systemic lupus erythematosus), autoimmune disorders or corneal degenerative conditions associated with peripheral corneal thinning such as rheumatoid arthritis and pellucid marginal degeneration that render LRI to be unsafe procedure with unpredicted outcomes.
Table
1 shows the study population groups’ demographic data.
Table 1Preoperative demographic data of the study population groups; Group-A: vertical LRIs and Group-B: horizontal LRIs
Number of patients | 13 | 15 | – |
Number of eyes | 21 | 21 | – |
Gender (Female) | 7 | 7 | 0.97 |
Age (Years) | 70.65 ± 9.50 | 75.25 ± 8.51 | 0.15 |
Preoperative TBUT (Sec) | 7.41 ± 2.48 | 8.81 ± 5.59 | 0.73 |
Preoperative BST (mm) | 14.71 ± 8.86 | 16.13 ± 9.32 | 0.61 |
The study protocol was approved by the institutional review board of Minia Faculty of Medicine Research Ethics Committee (FMREC) and compiled with the tenets of the Declaration of Helsinki. All study participants signed a written informed consent to participate in the study and for publication of data before being enrolled in the study; after explaining the nature and details of the study procedures.
All participants had the standard cataract surgery (phacoemulsification) performed simultaneously with LRIs. The horizontal axis (0–180°) was marked at the slit-lamp preoperatively while the patient was in sitting position to compensate for potential cyclotorsion when shifting to the supine position. The incisions were performed in the steepest corneal axis at the limbus just anterior to the palisades of Vogt for correcting preoperative corneal astigmatism which was documented preoperatively by the corneal topographer (ATLAS-9000, Carl Zeiss Meditec, Germany). LRIs were performed according to the modified Gills’ nomogram at the commencement of surgery using a guarded micrometer diamond blade set at 500 μm as paired arcuate incisions. At the end; the incisions were irrigated with a balanced salt solution (BSS). A standard phacoemulsification technique was performed thereafter through a clear corneal temporal 2.8 mm incision; consisted of anterior continuous curvilinear capsulorrhexis (CCC), nucleus emulsification, and cortex irrigation-aspiration and implantation of an acrylic IOL implant. Postoperatively, topical antibiotic (Ofloxacin 0.3%) and steroid (Prednisolone acetate 1%) medications were administered four times daily for 2 weeks and the dose was steadily reduced thereafter. As these medications were used temporarily only, we assumed that they were not a confounding factor contributing to the postoperative ocular surface changes; moreover topical steroids have been recently considered a main line in treating meibomian gland dysfunction and dry eye syndrome.
Tear film stability was assessed by the tear break-up time test which measures the interval between instillation of a sterile fluorescein strip moistened with saline applied to the inferior cul-de-sac and appearance of the first dry spots on the cornea; examination done using the cobalt-blue filter of the slit-lamp counting time in seconds needed for the first break of the precorneal tear film in a steady maintained gaze.
Tear volume was determined using basic Schirmer’s test in which sterile graded Schirmer’s paper strips placed in the lower fornix while the patient is asked to close his eyes for 5 min after which the paper is removed and amount of wetting is measured.
We quantitatively assessed the tear film stability and production by TBUT and basic Schirmer’s test respectively both preoperatively; at 1, 4 and 12 weeks postoperatively.
Statistical analysis
The Statistical Package of Social Sciences (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.) was adopted for tabulation and analysis the obtained data. Quantitative data were presented as mean ± standard deviation while qualitative data were expressed as number (n) and percentage (%). Kolmogorov- Smirnov for normality test was used to differentiate between parametric data and non-parametric data.
Paired Samples Student T-test was used to compare preoperative and postoperative values. Repeated measures analysis of variance (ANOVA) was used to evaluate the changes over time. A P value less than 0.05 was considered statistically significant.
The sample size in the study provided 95.6% statistical power at the 5% level to detect a 1-s difference in tear break-up time (TBUT), when the standard deviation (SD) of the mean difference was 1 s. Results.
We have compared 21 eyes of 15 patients who had vertical LRIs (Group-A) to age-matched 21 eyes of 13 patients who had horizontal LRIs (Group-B) simultaneously with phacoemulsification; we found statistically significant reduction in the tear film stability measured by TBUT preoperatively; at 1, 4 and 12 weeks postoperatively (P = 0.001). No statistically significant differences regarding Schirmer’s test except in the first postoperative week in Group-B (P = 0.04).
In group-A who had vertically-oriented LRIs; the preoperative TBUT was 7.41 ± 2.48 s; 4.94 ± 2.36, 4.82 ± 1.94 and 5.59 ± 1.77 s, 1, 4 and 12 weeks postoperatively, (ANOVA, p = 0.01). the preoperative Schirmer’s test value was 14.71 ± 8.86 s; 12.88 ± 8.05, 13.53 ± 8.97 and 12.35 ± 8.20 s, 1, 4 and 12 weeks postoperatively, (ANOVA, p = 0.88).
In group-B who had horizontally-oriented LRIs; the preoperative TBUT was 8.81 ± 5.59 s; 6.38 ± 3.79, 7.19 ± 6.45 and 4.50 ± 3.48 s, 1, 4 and 12 weeks postoperatively, (ANOVA, p = 0.04). the preoperative Schirmer’s test value was 16.13 ± 9.32 s; 10.56 ± 5.16, 10.63 ± 4.77 and 9.75 ± 6.57 s, 1, 4 and 12 weeks postoperatively, (ANOVA, p = 0.05).
Table
2 shows the preoperative TBUT and tear volume values compared to the postoperative values as well as analysis of the time-course changes compared between both study groups.
Table 2Postoperative tear film time-course changes compared to preoperative values between study groups
Group-A |
TBUT (Sec) | 7.41 ± 2.48 | 4.94 ± 2.36 | 4.82 ± 1.94 | 5.59 ± 1.77 | 0.01 | 0.01 | 0.003 | 0.001 |
BST (mm) | 14.71 ± 8.86 | 12.88 ± 8.05 | 13.53 ± 8.97 | 12.35 ± 8.20 | 0.88 | 0.39 | 0.62 | 0.16 |
Group-B |
TBUT (Sec) | 8.81 ± 5.59 | 6.38 ± 3.79 | 7.19 ± 6.45 | 4.50 ± 3.48 | 0.04 | < 0.001 | 0.03 | 0.001 |
BST (mm) | 16.13 ± 9.32 | 10.56 ± 5.16 | 10.63 ± 4.77 | 9.75 ± 6.57 | 0.05 | 0.04 | 0.18 | 0.05 |
To analyze the course of changes over time, we used the multiple comparison test which was found to be significant for TBUT in both groups A and B (P = 0.01 and 0.04 respectively) but not for tear volume production (P = 0.88 and 0.05 respectively).