Amniotic Membrane or Mitomycin-C Trabeculectomy?

Shuchi B. Patel, MD


September 12, 2014

Trabeculectomy With Mitomycin-C Versus Trabeculectomy With Amniotic Membrane Transplant: A Medium-term Randomized, Controlled Trial

Khairy HA, Elsawy MF
J Glaucoma. 2014 May 19. [Epub ahead of print]

Study Summary

The goal of the study was to evaluate the efficacy in lowering intraocular pressure (IOP) with a trabeculectomy and an amniotic membrane transplant (AMT) compared with the standard trabeculectomy with mitomycin-C (MMC). This study was a patient-masked, randomized controlled comparison trial involving 52 eyes of 52 patients with bilateral primary open-angle glaucoma. The main outcome for comparison was the IOP-lowering effect of both procedures. Surgery was considered successful if the patient's IOP was less than 22 mm Hg and the IOPs were lowered by more than 20% without the use of any medication.

All trabeculectomies were conducted with a fornix-based conjunctival flap and performed by a single surgeon. In the MMC group, 5 cellulose sponge fragments soaked with MMC 0.4 mg/mL were placed between the conjunctiva and the sclera for 2 minutes over the area of the scleral flap and extending up to the fornix. In the AMT group, a cryopreserved standard-sized amniotic membrane was placed as a single layer with its epithelium-basement membrane side up and the stromal side in contact with the eye. The membrane was secured in place with a pair of 10-0 nylon sutures, placed on either side of the limbal edge of the membrane. The rest of the trabeculectomy was performed similarly in both cases, and there were no intraoperative complications.

All patients showed significantly (P < .05) lower IOP on the first postoperative day compared with their respective preoperative IOPs with a nonsignificant (P > .05) difference between study groups. All patients, regardless of operative procedure, maintained significantly (P < .05) lower IOP compared with their respective preoperative IOPs until the end of 24 months' follow-up. There was no significant difference (P > .05) between both groups in the number of postoperative glaucoma medications used. The absolute value of IOP was lower in the AMT group, but the difference was not statistically significant at any point in the study. Furthermore, no serious complications were reported, such as wound leaks, endophthalmitis, or hyphema, in either group. The frequency of elevated blebs with normal vascularization was higher in the AMT group compared with the MMC group (P < .05).

In conclusion, amniotic membrane as an adjunct to trabeculectomy in place of MMC is equally efficacious in preventing fibrosis and in lowering IOP postoperatively.


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