Trabeculectomy with Mitomycin C: Outcomes and Risk Factors for Failure in Phakic Open-Angle Glaucoma

doi:10.1016/j.ophtha.2006.01.062

Ophthalmology

Volume 113, Issue 6, June 2006, Pages 930-936

Presented at: Association for Research in Vision and Ophthalmology Annual Meeting, May 2005, Ft. Lauderdale, Florida.

https://doi.org/10.1016/j.ophtha.2006.01.062 Get rights and content

Purpose

To evaluate long-term tonometric outcomes of trabeculectomy with adjunctive mitomycin C (MMC) and its efficacy in achieving a range of intraocular pressures (IOP) in phakic patients with open-angle glaucoma.

Design

Retrospective cohort study.

Methods

Three levels of success were defined by these criteria: (A) IOP ≤18 mmHg and IOP reduction of 20%; (B) IOP ≤15 mmHg and IOP reduction of 25%; and (C) IOP ≤12 and IOP reduction of 30%. Kaplan-Meier survival analyses were used to assess outcomes. Cox’s proportional hazard regression analysis was used to identify risk factors for failure.

Participants

Two hundred twenty-five phakic patients (292 eyes) with open-angle glaucoma, ≥40 years of age at time of trabeculectomy.

Main Outcome Measures

The primary outcome was qualified success rate (with or without medications) according to the defined criteria. Secondary outcomes include IOP level and number of medications at 1 and 3 years after surgery, postoperative complications, and need for further glaucoma surgery.

Results

Mean IOP (±standard deviation) decreased from 18.8 mmHg (±6.1 mmHg) before surgery to 11.3 mmHg (±4.5 mmHg) at 1 year and 11.1 mmHg (±4.2 mmHg) at 3 years (P<0.001 for both). The mean number of medications decreased from 2.8 (±1.0) to 0.4 (±0.7) at 1 year and 0.7 (±1.0) at 3 years (P<0.001 for both). The success rates were 85%, 84%, and 79% at 1 year for criteria A, B, and C, respectively; and 62%, 56%, and 46% for these criteria, respectively, at 3 years. Postoperative laser suture lysis was associated with a higher rate of failure for criteria B and C (P<0.001 for both), the hazard ratio (HR) was 1.7 for criteria B and 2.0 for criteria C. Prior argon laser trabeculoplasty was associated with higher risk of failure for criteria C (HR = 1.6; P = 0.05).

Conclusions

Trabeculectomy with MMC effectively reduces IOP in phakic open-angle glaucoma, but long-term low IOPs are achieved in only half of the cases. Laser suture lysis after trabeculectomy and prior argon laser trabeculoplasty are associated with a higher risk of failure when low IOPs are required.

Section snippets

Patients

This is a retrospective cohort study of patients with open-angle glaucoma who underwent initial trabeculectomy with adjunctive MMC between August, 1997, and December, 2003, at the Glaucoma Division, Jules Stein Eye Institute, University of California Los Angeles. Two hundred twenty-five phakic patients (292 eyes) with primary open-angle, normal-tension, exfoliative, or pigmentary glaucoma who were 40 years of age or older at the time of trabeculectomy were considered for the study. Eyes that

Preoperative and Intraoperative Characteristics

From August, 1997, through December, 2003, a total of 638 trabeculectomies were performed at the Glaucoma Division, Jules Stein Eye Institute, by one of the authors (JC). Two hundred ninety-two phakic eyes were eligible for the study and 346 were excluded. Eighty-nine eyes were pseudophakic at the time of trabeculectomy, and 39 had undergone prior trabeculectomy. Other criteria for exclusion were narrow or closed angle glaucoma, uveitic glaucoma, traumatic glaucoma, aphakia, age younger than 40

Discussion

The adjunctive use of MMC with trabeculectomy more effectively reduces IOP in the short-term than standard trabeculectomy without antimetabolites.21, 22 The success of trabeculectomy often has been defined arbitrarily as a lowering of the IOP to less than 21 mmHg or a reduction of the IOP by a certain percentage. However, contemporary IOPs often are well below the traditional 21-mmHg level. By setting the cutoff IOP for success at 21 mmHg, the success rate of filtering surgery is overestimated.

References (46)

P.R. Lichter et al.
Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery
Ophthalmology
(2001)
K. Singh et al.
Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil. Prospective randomized clinical trial
Ophthalmology
(2000)
D.K. Heuer et al.
5-Fluorouracil and glaucoma filtering surgery. II
Ophthalmology
(1984)
G.L. Skuta et al.
Intraoperative mitomycin versus postoperative 5-fluorouracil in high-risk glaucoma filtering surgery
Ophthalmology
(1992)
M.F. Smith et al.
Results of intraoperative 5-fluorouracil supplementation on trabeculectomy for open-angle glaucoma
Am J Ophthalmol
(1992)
P.R. Egbert et al.
A prospective trial of intraoperative fluorouracil during trabeculectomy in a black population
Am J Ophthalmol
(1993)
E.J. Higginbotham et al.
Bleb-related endophthalmitis after trabeculectomy with mitomycin C
Ophthalmology
(1996)
K. Nouri-Mahdavi et al.
Outcomes of trabeculectomy for primary open-angle glaucoma
Ophthalmology
(1995)
J.S. Mora et al.
Trabeculectomy with intraoperative sponge 5-fluorouracil
Ophthalmology
(1996)
Y.Y. Kim et al.
Outcomes of primary phakic trabeculectomies without versus with 0.5- to 1-minute versus 3- to 5-minute mitomycin C
Am J Ophthalmol
(1998)

T.H. Kupin et al.

Adjunctive mitomycin C in primary trabeculectomy in phakic eyes

Am J Ophthalmol

(1995)

L.K. Mao et al.

Correlation between intraocular pressure control and progressive glaucomatous damage in primary open-angle glaucoma

Am J Ophthalmol

(1991)

B. Bergea et al.

Impact of intraocular pressure regulation on visual fields in open-angle glaucoma

Ophthalmology

(1999)

G. Rebolleda et al.

Effect of cataract surgery on IOP after trabeculectomy [letter]

J Cataract Refract Surg

(2003)

K. Hayashi et al.

Effect of cataract surgery on intraocular pressure control in glaucoma patients

J Cataract Refract Surg

(2001)

B.J. Shingleton et al.

Long-term changes in intraocular pressure after clear corneal phacoemulsificationnormal patients versus glaucoma suspect and glaucoma patients

J Cataract Refract Surg

(1999)

R.L. Stamper et al.

Hypotonous maculopathy after trabeculectomy with subconjunctival 5-fluorouracil

Am J Ophthalmol

(1992)

M.B. Shields et al.

Clinical and histopathologic observations concerning hypotony after trabeculectomy with adjunctive mitomycin C

Am J Ophthalmol

(1993)

R. Bindlish et al.

Efficacy and safety of mitomycin-C in primary trabeculectomyfive-year follow-up

Ophthalmology

(2002)

A. Azuara-Blanco et al.

Dysfunctional filtering blebs

Surv Ophthalmol

(1998)

R. Parrish et al.

“Late endophthalmitis”—filtering surgery time bomb?

Ophthalmology

(1996)

A.P. Wells et al.

Cystic bleb formation and related complications in limbus- versus fornix-based conjunctival flaps in pediatric and young adult trabeculectomy with mitomycin C

Ophthalmology

(2003)

C. Migdal et al.

Long-term functional outcome after early surgery compared with laser and medicine in open-angle glaucoma

Ophthalmology

(1994)

Cited by (166)

Hypotony Failure Criteria in Glaucoma Surgical Studies and Their Influence on Surgery Success
2024, Ophthalmology
Review hypotony failure criteria used in glaucoma surgical outcome studies and evaluate their impact on success rates.
Systematic literature review and application of hypotony failure criteria to 2 retrospective cohorts.
A total of 934 eyes and 1765 eyes undergoing trabeculectomy and deep sclerectomy (DS) with a median follow-up of 41.4 and 45.4 months, respectively.
Literature-based hypotony failure criteria were applied to patient cohorts. Intraocular pressure (IOP)-related success was defined as follows: (A) IOP ≤ 21 mmHg with ≥ 20% IOP reduction; (B) IOP ≤ 18 mmHg with ≥ 20% reduction; (C) IOP ≤ 15 mmHg with ≥ 25% reduction; and (D) IOP ≤ 12 mmHg with ≥ 30% reduction. Failure was defined as IOP exceeding these criteria in 2 consecutive visits > 3 months after surgery, loss of light perception, additional IOP-lowering surgery, or hypotony. Cox regression estimated failure risk for different hypotony criteria, using no hypotony as a reference. Analyses were conducted for each criterion and hypotony type (i.e., numerical [IOP threshold], clinical [clinical manifestations], and mixed [combination of numerical or clinical criteria]).
Hazard ratio (HR) for failure risk.
Of 2503 studies found, 278 were eligible, with 99 studies (35.6%) lacking hypotony failure criteria. Numerical hypotony was predominant (157 studies [56.5%]). Few studies used clinical hypotony (3 isolated [1.1%]; 19 combined with low IOP [6.8%]). Forty-nine different criteria were found, with IOP < 6 mmHg, IOP < 6 mmHg on ≥ 2 consecutive visits after 3 months, and IOP < 5 mmHg being the most common (41 [14.7%], 38 [13.7%], and 13 [4.7%] studies, respectively). In both cohorts, numerical hypotony posed the highest risk of failure (HR, 1.51–1.21 for criteria A to D; P < 0.001), followed by mixed hypotony (HR, 1.41–1.20 for criteria A to D; P < 0.001), and clinical hypotony (HR, 1.12–1.04; P < 0.001). Failure risk varied greatly with various hypotony definitions, with the HR ranging from 1.02 to 10.79 for trabeculectomy and 1.00 to 8.36 for DS.
Hypotony failure criteria are highly heterogenous in the glaucoma literature, with few studies focusing on clinical manifestations. Numerical hypotony yields higher failure rates than clinical hypotony and can underestimate glaucoma surgery success rates. Standardizing failure criteria with an emphasis on clinically relevant hypotony manifestations is needed.
Proprietary or commercial disclosure may be found after the references.
Ab interno trabeculectomy revision with 5-flourouracil for failed trabeculectomy in advanced glaucoma: 3-year outcomes
2024, Canadian Journal of Ophthalmology
To describe the 3-year outcomes of patients who underwent ab interno trabeculectomy revision with a translimbal sclerostomy spatula augmented with 5-flourouracil.
Retrospective cohort study.
In this single-centre study, inclusion criteria included patients who were 18 years of age or older with advanced glaucoma who had undergone ab interno trabeculectomy revision with 5-flourouracil due to subconjunctival fibrosis and above-target intraocular pressure (IOP). Patients were required to have a minimum follow-up of 3 years.
The primary outcome measure was IOP. Secondary outcome measures included number of topical IOP-lowering medications, best-corrected distance visual acuity, visual field mean deviation, and postoperative complications.
Forty-one eyes of 41 patients met the criteria for inclusion. Survival analysis demonstrated success defined by criterion A (IOP <15 mm Hg and >20% reduction) in 44% of eyes without medication (complete success) and 71% of eyes with or without medication (qualified success) at 3-year follow-up. Complete and qualified successes defined by criterion B (IOP <12 mm Hg and >20% reduction) were achieved by 31% and 44% of eyes, respectively. Early complications included transient hypotony in 26 eyes (63%) and transient hyphema in 3 eyes (7.3%). No persistent complications were reported within the 3-year study period.
Ab interno trabeculectomy revision can be an effective technique for achieving a low target IOP in patients with advanced glaucoma in up to 3-year follow-up.
Risk Factors for Failure of Tube Shunt Surgery: A Pooled Data Analysis
2022, American Journal of Ophthalmology
To identify the risk factors associated with failure of tube shunt surgery.
Pooled analysis of 3 prospective multicenter, randomized clinical trials.
A total of 621 patients with medically uncontrolled glaucoma were enrolled, including 276 from the Ahmed Baerveldt Comparison Study, 238 from the Ahmed Versus Baerveldt Study, and 107 from the tube group of the Tube Versus Trabeculectomy Study. Patients were randomized to treatment with an Ahmed glaucoma valve (model FP7) or Baerveldt glaucoma implant (model 101-350). The associations between baseline risk factors and tube shunt failure were assessed using a Cox proportional hazards regression model. The primary outcome measure was the rate of surgical failure defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, loss of light perception vision, reoperation for glaucoma, or removal of implant.
The cumulative probability of failure after tube shunt surgery was 38.3% after 5 years. In multivariable analyses, baseline factors that predicted tube shunt failure included preoperative IOP (≤ 21 mmHg compared to IOP > 21 and ≤ 25 mmHg; HR, 2.34; 95% CI, 1.52-3.61; P < .001), neovascular glaucoma (HR, 1.79; 95% CI, 1.28-2.52; P = .001), randomized treatment (for Ahmed glaucoma valve; HR, 1.36; 95% CI, 1.04-1.78; P = .025), and age (for 10 year decrease in age; HR, 1.19; 95% CI, 1.09–1.31; P < .001).
Lower preoperative IOP, neovascular glaucoma, Ahmed implantation, and younger age were predictors of tube shunt failure. This Study provides the largest prospectively collected dataset on tube shunt surgery.
Primary Deep Sclerectomy in Open-Angle Glaucoma: Long-Term Outcomes and Risk Factors for Failure
2021, Ophthalmology Glaucoma
To report long-term outcomes of primary deep sclerectomy (DS) in open-angle glaucoma (OAG) and identify factors influencing surgical failure and postoperative complications.
Retrospective cohort study.
Consecutive OAG patients undergoing primary DS with follow-up of 1 year or more.
Three intraocular pressure (IOP) success cutoffs were defined: 18 mmHg or less and 20% reduction, 15 mmHg or less and 25% reduction, and 12 mmHg or less and 30% reduction. Cox multivariable regression analysis investigated factors influencing failure and postoperative complications.
The primary outcome was the success rate of DS according to the defined criteria. Secondary outcomes included IOP over time and factors predictive of failure.
Five hundred thirteen eyes of 409 patients with a mean age ± standard deviation (SD) of 70.2 ± 9.8 years and follow-up of 84.1 ± 41.6 months. Mean ± SD IOP decreased from 23.5 ± 7.3 mmHg to 13.3 ± 3.9 mmHg, 12.8 ± 4.3 mmHg, and 12.4 ± 4.3 mmHg at 3, 5, and 7 years, respectively (P < 0.001). Success rates at 3, 5, and 7 years were 66.3% (95% Confidence Interval [CI] 62.2%–70.7%), 57.9% (95% CI 53.4%–62.7%), and 54.0% (95% CI 49.4%–59.1%), respectively, for IOP of 18 mmHg or less; 44.5% (95% CI 40.3%–49.1%), 34.6% (95% CI 30.4%–39.4%), and 29.8% (95% CI 25.6%–34.6%), respectively, for IOP of 15 mmHg or less; and 18.1% (95% CI 15.0%–21.9%), 11.9% (95% CI 9.2%–15.4%), and 10.0% (95% CI 7.5%–13.4%), respectively, for IOP of 12 mmHg or less. For all cutoffs, laser goniopuncture (P < 0.001), needling (P < 0.001), and postoperative antiglaucoma medications (P < 0.001) were associated with increased failure. Intraoperative mitomycin C (MMC) was associated with reduced failure for IOP of 15 mmHg or less (P = 0.006) and IOP of 12 mmHg or less (P = 0.001), whereas higher preoperative IOP (P = 0.001) with increased failure for IOP of 12 mmHg or less.
Deep sclerectomy is an effective, long-lasting primary surgical procedure for OAG. Intraoperative MMC enhances survival, whereas higher preoperative IOP and postoperative maneuvers are predictors of increased failure.
Comparison between Mitomycin-C and Ologen Implants in the Treatment of Primary Open Glaucoma by Subscleral Trabeculectomy
2024, Research Square
PRESERFLO MicroShunt implantation versus trabeculectomy for primary open-angle glaucoma: a two-year follow-up study
2023, Eye and Vision

View all citing articles on Scopus

Manuscript no. 2005-630.

Supported by unrestricted grants from Research to Prevent Blindness Inc., New York, New York; Fight for Sight Inc., New York, New York; and Allergan Inc., Irvine, California.

View full text

Original ArticleTrabeculectomy with Mitomycin C: Outcomes and Risk Factors for Failure in Phakic Open-Angle Glaucoma

Purpose

Design

Methods

Participants

Main Outcome Measures

Results

Conclusions

Section snippets

Patients

Preoperative and Intraoperative Characteristics

Discussion

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

Ophthalmology

Ophthalmology

Am J Ophthalmol

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

J Cataract Refract Surg

J Cataract Refract Surg

J Cataract Refract Surg

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

Surv Ophthalmol

Ophthalmology

Ophthalmology

Long-term functional outcome after early surgery compared with laser and medicine in open-angle glaucoma

Ophthalmology

Original Article
Trabeculectomy with Mitomycin C: Outcomes and Risk Factors for Failure in Phakic Open-Angle Glaucoma