Treatment Outcomes of Mitomycin C-Augmented Trabeculectomy, Sub-Tenon Injection versus Soaked Sponges, after 3 Years of Follow-up: A Randomized Clinical Trial

Hamed Esfandiari, Mohammad Pakravan, Shahin Yazdani, Azadeh Doozandeh, Mehdi Yaseri, Ian P. Conner

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

Purpose: To report the 3-year outcome of trabeculectomy with mitomycin C (MMC)-soaked sponges versus intra-Tenon injection of MMC in eyes with uncontrolled primary open-angle glaucoma. Design: Randomized clinical trial. Participants: Eighty-two consecutive patients with uncontrolled primary open-angle glaucoma. Methods: Participants were randomized either to intra-Tenon injection of 0.1 ml of 0.01% MMC (TI group) or 0.02% subconjunctival application of MMC-soaked sponges (TS group). Patients were followed up for 3 years after surgery. The data for 73 eyes were included in the final analysis. Main Outcome Measures: The primary outcome measure was the surgical success, defined as intraocular pressure (IOP) more than 5 mmHg and <21 mmHg, and IOP reduction of 20% or more from baseline, no reoperation for glaucoma, and no loss of light perception vision. Secondary outcome measures were IOP, glaucoma medications, best-corrected visual acuity (VA), bleb morphologic features according to the Indiana Bleb Appearance Grading Scale, complications, and endothelial cell count changes. Results: The cumulative probability of success at 3-year follow-up was 72.2% in the TI group and 65.1% in the TS group (P = 0.30). Uncontrolled IOP was the most common reason for failure. The mean preoperative IOP was 22.4±4.6 mmHg with an average of 3.1±1.0 medications. At 3 years, final IOP was 15.3±3.7 mmHg in the TI group and 16.4±3.5 mmHg in the TS group (P = 0.55). Mean glaucoma number of medications was 0.9±1.1 and 1.1±1.1 in the TI and TS groups, respectively (P = 0.54). Blebs tended to be more diffuse (P = 0.032), less vascularized (P = 0.013), and more shallow (P = 0.012) after intra-Tenon injection. Visual outcomes and endothelial cell changes were similar in both groups (P = 0.47 and P = 0.94, respectively). Conclusions: Although the success rate and IOP reduction were comparable with both techniques, bleb morphologic parameters were more favorable after intra-Tenon injection of 0.1 ml of 0.01% MMC.

Original languageEnglish (US)
Pages (from-to)66-74
Number of pages9
JournalOphthalmology Glaucoma
Volume1
Issue number1
DOIs
StatePublished - Jul 1 2018
Externally publishedYes

ASJC Scopus subject areas

  • Ophthalmology
  • General Medicine

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