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Original Article
Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial
  1. Mohammad Pakravan1,
  2. Hamed Esfandiari2,
  3. Shahin Yazdani2,3,
  4. Azadeh Douzandeh2,
  5. Nassim Amouhashemi2,
  6. Mehdi Yaseri4,
  7. Parto Pakravan5
  1. 1 Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2 Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  3. 3 Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  4. 4 Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  5. 5 Orange Coast College, Irvine, California, USA
  1. Correspondence to Dr Hamed Esfandiari, Department of Ophthalmology, Labbafinejad Medical Center, Boostan 9 St., Pasdaran Ave., Tehran 16666-94516, Iran; hmdesfandiary{at}gmail.com

Abstract

Background/aims To compare the efficacy and safety of subtenon injection of mitomycin C (MMC) with that of conventional application of MMC-soaked sponges in trabeculectomy.

Methods In this multicentre randomised clinical trial, 80 consecutive open-angle glaucoma cases were randomised into two groups; group 1 received a subtenon injection of 0.1 mL of 0.01% MMC, while group 2 received 0.02% MMC-soaked sponges. Primary outcome measure was intraocular pressure (IOP), and secondary outcome measures were endothelial cell count (ECC) changes and bleb morphology according to the Indiana Bleb Appearance Grading Scale. Outcome measures were compared at 1, 3 and 6 months postoperatively. Complete and qualified success was defined as IOP within 6–15 mm Hg without and with medications at month 6, respectively.

Results Mean preoperative IOP was 21.8±5.1 in group 1, which reduced to 10.3±3.7 mm Hg at final visit (p<0.001). Corresponding values for group 2 were 21.8±5 and 10.8±3.5 mm Hg respectively (p<0.001). Complete success was 82.5% in both groups, and qualified success was 0 and 2.5% in groups 1 and 2, respectively. (p=0.316) The blebs tended to be more diffuse, less vascularised and shallower in group 1, at month 6 (p=0.45,<0.001 and <0.007 respectively). ECCs did not change significantly at final visit (p=0.813).

Conclusions Subtenon injection of MMC is a safe and effective alternative to the conventional soaked sponge method. This method produces more favourable bleb morphology after trabeculectomy.

Trial registration number NCT02385370, Post-results.

  • Glaucoma
  • Clinical Trial
  • Treatment Surgery

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Footnotes

  • Contributors Study conception and design, acquisition/analysis/interpretation of data: MP, HE, SY, AD. Drafting the article or revising it critically: MP, HE, SY, AD, NA, MY, PP. Final approval of the version to be submitted: MP, HE, SY, AD, NA, MY, PP.

  • Competing interests None declared.

  • Ethics approval The study was approved by the Ethics Committee at the Ophthalmic Research Center of Shahid Beheshti University of Medical Science.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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