Joni Hoop

Long-term Outcomes of Intraoperative 5-Fluorouracil versus Intraoperative Mitomycin C in Primary Trabeculectomy Surgery

OBJECTIVE To compare the long-term efficacy of intraoperative 5-fluorouracil (5-FU) and mitomycin C (MMC) in primary trabeculectomy. DESIGN Comparative case series and extension of a prospective, randomized controlled trial. PARTICIPANTS One hundred fifteen eyes of 103 subjects undergoing primary trabeculectomy with either intraoperative 5-FU or MMC. METHODS This study is an extension of a 12-month, prospective, double-masked, randomized trial that previously was reported. Subjects were randomized to receive either intraoperative 5-FU (50 mg/ml for 5 minutes) or MMC (0.2 mg/ml for 2 minutes) during primary trabeculectomy. Follow-up data were collected from patient medical records after informed consent was obtained from the study patient. Attempts were made to contact subjects who had been lost to follow-up, and some consented to reexamination. MAIN OUTCOME MEASURES The primary measure was Kaplan-Meier survival function, with failure defined as intraocular pressure (IOP) of more than 21 mmHg or less than 6 mmHg on 2 consecutive visits, less than 20% reduction from baseline IOP, loss of light perception vision, or additional glaucoma surgery to lower IOP (except bleb revision). Secondary measures included IOP, number of glaucoma medications, visual acuity, additional surgeries, and number and type of complications. RESULTS Mean follow up was 53.4+/-31.4 months (interquartile range, 34-82 months) in the 5-FU group and 45.3+/-28.0 months (interquartile range, 19-70 months) in the MMC group (P = 0.15, t test). Kaplan-Meier success was 0.83 at 3 years and 0.76 at 5 years in the 5-FU group and 0.79 at 3 years and 0.66 at 5 years in the MMC group (P = 0.18, log-rank test). Bleb leakage was the most common complication in each group and developed in approximately 4% of subjects in each group per year (P = 0.33, log-rank test). CONCLUSIONS There were no significant differences between topical 5-FU and topical MMC in reducing IOP of eyes undergoing primary trabeculectomy. Both antifibrosis agents may contribute to the development of bleb leakage. FINANCIAL DISCLOSURE(S) The author(s) have no proprietary or commercial interest in any materials discussed in this article.

A prospective randomized trial comparing intraoperative 5-fluorouracil vs mitomycin C in primary trabeculectomy.

PURPOSE To compare the safety and efficacy of intraoperative 5-fluorouracil (5-FU) or Intraoperative mitomycin C (MMC) in eyes undergoing primary trabeculectomy. DESIGN Prospective double-masked randomized clinical trial. METHODS One hundred fifteen eyes of 103 patients with uncontrolled intraocular pressure (IOP) despite maximally tolerated medical therapy or laser were prospectively randomized in a double-masked fashion to one of two treatment groups in a single institution setting. Subjects eyes underwent primary trabeculectomy with either topical 5-FU (50 mg/ml for 5 minutes) or topical MMC (0.2 mg/ml for 2 minutes). Primary outcome measures included the number of eyes achieving target pressures of 21, 18, 15, and 12 mm Hg at 6 and 12 months postoperatively. Secondary outcome measures included IOP, best-corrected visual acuity, complications, and interventions. RESULTS Of the 115 eyes, 57 received 5-FU while 58 received MMC. A target IOP of 21 mm Hg at 6 months was achieved in 53 of 56 (95%) eyes in the 5-FU group and 54 of 57 (95%) eyes in the MMC group (P = 1.00). At 12 months, 45 of 48 (94%) eyes in the 5-FU group met a target IOP of 21 mm Hg while 48 of 54 (89%) eyes in the MMC group did (P =.49). The most common complications in each group were persistent choroidal effusions and bleb leak. CONCLUSION Our study suggests that intraoperative topical 5-FU is at least as effective as intraoperative topical MMC in reducing IOP of eyes undergoing primary trabeculectomy.

The effect of mitomycin C on Molteno implant surgery: a 1-year randomized, masked, prospective study.

PURPOSE The authors assess whether adjunctive mitomycin C improves Molteno tube shunt surgery in terms of intraocular pressure (IOP), visual acuity, and complication rates. PATIENTS AND METHODS Twenty-five eyes of twenty-five consecutive patients undergoing double-plate Molteno implant surgery were randomized to receive either mitomycin C (MMC) 0.4 mg/mL for 2 minutes or a control balanced salt solution in a masked, prospective study. Intraocular pressure, visual acuity, and complications were recorded 1 week and 1, 3, 6, and 12 months after surgery. A repeated measures analysis of variance (ANOVA) model was used to test the overall effect of the drug on IOP and percent change from preoperative IOP. RESULTS Thirteen eyes received balanced salt solution and 12 eyes received MMC. There was no difference between the groups with respect to age, preoperative IOP, log mean angle of resolution (LogMar) visual acuity, or number of preoperative medications. Except for week 1, there were no differences between the groups at any of the clinic visits with respect to IOP and percent change from baseline IOP. Analysis of the visual acuity (LogMar) showed reduction in vision for both groups. Complications were similar in each group, as were number of postoperative hypotensive agents required. CONCLUSIONS Adjunct MMC does not demonstrate a significant difference in outcomes compared with placebo in pressure-ridged Molteno implant surgery. Results of this study are limited by a small number of patients in each group and a fixed dose of MMC.

Intraocular pressure-lowering efficacy of bimatoprost 0.03% and travoprost 0.004% in patients with glaucoma or ocular hypertension

Aim: To evaluate the efficacies of bimatoprost and travoprost for lowering of intraocular pressure (IOP) for the treatment of glaucoma and ocular hypertension. Methods: Prospective, randomised, investigator-blinded, parallel-group clinical trial. After completing a washout of all glaucoma drugs, patients (n = 157) were randomised to bimatoprost or travoprost for 6 months. Visits were at baseline, 1 week, and 1, 3 and 6 months. IOP was measured at 09:00 h at each visit and also at 13:00 and 16:00 h at baseline and at 3 and 6 months. Results: No significant between-group differences were observed in IOP at baseline, at 09:00, 13:00 or 16:00 h (p⩾0.741). After 6 months, both drugs significantly reduced IOP at every time point (p⩽0.001). After 6 months, mean IOP reduction at 09:00 h was 7.1 mm Hg (27.9%) with bimatoprost (n = 76) and 5.7 mm Hg (23.3%) with travoprost (n = 81; p = 0.014). At 13:00 h, mean IOP reduction was 5.9 mm Hg with bimatoprost (25.3%) and 5.2 mm Hg (22.4%) with travoprost (p = 0.213). At 16:00 h, the mean IOP reduction was 5.3 mm Hg (22.5%) with bimatoprost and 4.5 mm Hg (18.9%; p = 0.207) with travoprost. Both study drugs were well tolerated, with ocular redness the most commonly reported adverse event in both treatment groups. Conclusions: Bimatoprost provided greater mean IOP reductions than travoprost.

Optic nerve head (ONH) topographic analysis by stratus OCT in normal subjects: correlation to disc size, age, and ethnicity.

PurposeTo study optic nerve head (ONH) topography parameters measured by Stratus optical coherence tomography (OCT) in normal subjects and to analyze ONH data for differences in relation to disc size, ethnicity, and age. MethodsThree hundred sixty-seven normal subjects underwent Stratus optical coherence tomography ONH measurement using the fast optic disc scan protocol software package 3.0. Only ONH scans meeting specific qualification criteria were included for data analysis ensuring appropriate scan quality and reliability. ONH topographic parameters of qualified scans were analyzed for differences in regards to optic disc size, age, and ethnicity. ResultsTwo hundred and twelve qualified ONH scans were included for data analysis. Mean disc area was 2.27±0.41 mm2 and optic cup area, rim area, and horizontal integrated rim width increased with disc size, whereas vertical integrated rim area did not. Vertical integrated rim area, horizontal integrated rim width, and rim area decreased and cup area increased with age. Mean optic disc area was larger in African-Americans as compared with Hispanics or Whites and this difference was statistically significant. ConclusionsOptic cup area, rim area, and horizontal integrated rim width correlated to disc size. Vertical integrated rim area, horizontal integrated rim width, rim area, and cup area, changed with age. African-American optic discs had larger disc area measurements as compared with Whites optic discs and this difference was statistically significant.

Levels of bimatoprost acid in the aqueous humour after bimatoprost treatment of patients with cataract.

Aim: To determine the aqueous humour concentration of the acid hydrolysis products of bimatoprost and latanoprost after a single topical dose of bimatoprost 0.03% or latanoprost 0.005% in humans. Methods: Randomised, controlled, double-masked, prospective study. 48 eyes of 48 patients scheduled for routine cataract surgery were randomised in an 8:2:2 ratio to treatment with a single 30 μl drop of bimatoprost 0.03%, latanoprost 0.005% or placebo at 1, 3, 6 or 12 h before the scheduled cataract surgery. Aqueous humour samples were withdrawn at the beginning of the surgical procedure and analysed using high-performance liquid chromatography–tandem mass spectrometry. Results: Bimatoprost acid (17-phenyl trinor prostaglandin F2α) was detected in aqueous samples at a mean concentration of 5.0 nM at hour 1, 6.7 nM at hour 3 and 1.9 nM at hour 6 after bimatoprost treatment. After latanoprost treatment, the mean concentration of latanoprost acid (13,14-dihydro-17-phenyl trinor prostaglandin F2α) in aqueous samples was 29.1 nM at hour 1, 41.3 nM at hour 3 and 2.5 nM at hour 6. Acid metabolites were below the limit of quantitation in all samples taken 12 h after dosing and in all samples from placebo-treated patients. None of the samples from latanoprost-treated patients contained quantifiable levels of non-metabolised latanoprost. Non-metabolised bimatoprost was detected in aqueous samples at a mean concentration of 6.6 nM at hour 1 and 2.4 nM at hour 3 after bimatoprost treatment. Conclusions: Low levels of bimatoprost acid were detected in aqueous humour samples from patients with cataract treated with a single dose of bimatoprost. Latanoprost acid concentrations in samples from patients treated with latanoprost were at least sixfold higher. These results suggest that bimatoprost acid in the aqueous humour does not sufficiently account for the ocular hypotensive efficacy of bimatoprost.

Mitomycin C in higher risk trabeculectomy: A prospective comparison of 0.2- to 0.4-mg/cc Doses

PURPOSE This randomized, masked, prospective study was conducted to compare the outcome of filtering surgery using doses of 0.2 mg/cc or 0.4 mg/cc of mitomycin C (MMC) in eyes that were at higher risk from previous conjunctival incisional surgery. METHODS Eyes of 50 consecutive patients with primary open-angle, pseudoexfoliation, or pigmentary glaucoma requiring trabeculectomy who had previously undergone either limbal cataract surgery or trabeculectomy were enrolled. Patients received an intraoperative dose of either 0.2 or 0.4 mg/cc MMC for 2 minutes (n = 25 in each study group). Intraocular pressure (IOP), logMAR visual acuity, and complications were monitored at regular intervals for 1 year. Unpaired student t tests were used to compare percent decrease in IOP in both study groups at each interval. RESULTS The percent decrease in IOP was not significantly different between groups at 1 day, 1 week, 1 month, 3 months, 6 months, or 1 year after surgery. LogMAR visual acuity was not significantly different between groups at 1 month, 6 months, or 1 year. Treatment failure occurred in seven patients in the 0.2 mg/cc group (28%) and seven patients in the 0.4 mg/cc group (29.2%). Postoperative hypotony, choroidal effusions and hemorrhages, and wound leaks occurred in both groups, but occurred more often in the group receiving 0.4 mg/cc MMC. CONCLUSION Filtering surgery performed on higher risk eyes was as effective using a lower dose (0.2 mg/cc) of MMC as that using a higher dose (0.4 mg/cc). Incidence of complications and treatment failures was slightly higher in the group receiving high-dose MMC.

Cataract surgery after tube shunts.

Purpose: To determine the effect of cataract surgery on glaucomatous eyes with functioning tube shunts. Methods: Retrospective analysis of 11 eyes of 11 patients with functioning tube shunts who underwent cataract extraction. Results: The mean follow‐up after cataract extraction was 21 ± 27 months (range, 4–97 months). There was no statistically significant difference between the mean preoperative intraocular pressure and mean postoperative intraocular pressure (17.4 ± 3.7 mm Hg vs 17.8 ± 5.9 mmHg; P = 0.85, paired t test). Most patients exhibited a statistically significant rise or drop in pressure, but in none was there a clinically significant change. The mean number of preoperative and postoperative antiglaucoma medications was also not significantly different (1.5 ± 1.1 vs 1.7 ± 1.2; P = 0.44, paired t test). Snellen visual acuity improved at least 2 lines in 6 eyes (55%). Complications after cataract extraction included corneal edema in three eyes, one of which had subsequent loss of control of intraocular pressure. Conclusions: Eyes with a functioning tube shunt undergoing cataract extraction can maintain control of intraocular pressure while achieving visual improvement.

Measurement of iris color using computerized image analysis

Purpose. To develop a standardized method for measuring from iris photographs, light and dark segments of areas and densities of iris color. Methods. Computerized image analysis was used to measure the iris photographs. The reproducibility of this method was studied in 30 normal eyes with three different colored irides, green-brown, blue-grey brown and yellow-brown. Three photographs were taken of each iris with a slit lamp camera at three different exposures at baseline. The photographs were repeated with exposure providing for the best reproducibility at 6.5 ± 1.7 months as a first follow-up after baseline and 3.6 ± 0.8 months following the first follow-up visit. At least one measurement was made for each photograph. Results. The mean percent coefficient of variation (standard deviation of triplicate measurements/mean × 100) ranged from 1.0 to 4.1% for area and density measurements. Furthermore, the range of mean percent differences between baseline and follow-up visits ranged from 1.2 to 6.3%. Conclusion. We have developed a standardized method which appears suitable for measuring changes over time in iris color.

Efficacy, safety, and survival rates of IOP-lowering effect of phacoemulsification alone or combined with canaloplasty in glaucoma patients.

Purpose:To evaluate efficacy and survival rates of intraocular pressure (IOP)-lowering effect obtained with phacoemulsification (phaco) alone or in combination with canaloplasty (PCP) in patients with open-angle glaucoma (OAG). Methods:Retrospective chart review of consecutive cases at the Department of Ophthalmology, Indiana University. Visual acuity (VA), IOP, number of medications (Meds), failures, and survival rates of IOP-lowering effect were analyzed. Inclusion criteria were: patients older than 18 years with OAG and cataract. Exclusion criteria were: no light perception vision, prior glaucoma surgery, chronic uveitis, angle-closure glaucoma, and advanced-stage or end-stage OAG. Failure criteria were: IOP>21 mm Hg or <20% reduction, IOP<6 mm Hg, further glaucoma surgeries, and loss of light perception vision. Results:Thirty-seven patients underwent phaco and 32 patients had PCP. Follow-up was 21.8±10.1 versus 18.8±9.6 months for phaco and PCP, respectively (P=0.21). Age (y) (74.7±9.8 vs. 76.1±8.3, P=0.54), sex (P=81), and laser status (P=0.75) were similar between the groups. Preoperatively, mean±SD logMAR VA (0.5±0.7 vs. 0.5±0.5, P=0.77), IOP (16.2±4.6 vs. 18.2±5.1, P=0.13), and Meds (1.4±1.1 vs. 1.3±0.7, P=0.75) were similar for phaco and PCP, respectively. At 24-month phaco (n=17) and PCP (n=11), respectively, mean±SD were: logMAR VA 0.2±0.2 versus 0.4±0.7, P=0.29; IOP 14.1±4.0 versus 12.9±3.8, P=0.43; and Meds 1.5±1.2 versus 0.3±0.5, P=0.005. Rates of successful IOP lowering without medications for phaco versus PCP at 12 months were 34% versus 75%, respectively (P=0.003). Conclusions:A combination of canaloplasty with phaco results in a decreased number of glaucoma medications and increased survival rate of IOP-lowering effect compared with phaco alone.