Comparing Innovative Tube Trabeculectomy and Conventional Surgery for Advanced and Refractory Glaucoma in Adults

What this Trial Is About

Researchers are evaluating a new surgical method called Innovative Tube Trabeculectomy ITT compared to the standard conventional trabeculectomy in adults with advanced or refractory open-angle glaucoma. The goal is to see if ITT can better control eye pressure and reduce complications, potentially improving outcomes for patients who have not responded well to other treatments. This randomized controlled trial is conducted at a single center and focuses on surgical success and safety over a 12-month period. Participants will be randomly assigned to receive either the ITT procedure or the conventional trabeculectomy. The ITT group will follow a specific preoperative regimen lasting 3 weeks that involves stopping certain eye medications and starting new ones, followed by a 1-week injection of medications including Mitomycin C, Avastin, and Dexamethasone before surgery. The surgical technique includes creating a deep scleral tunnel, applying Mitomycin C during surgery, using a special X-shaped suture, and implanting a nasolacrimal tube. The conventional group will receive standard trabeculectomy with Mitomycin C applied during surgery as per usual practice. During the 12 months following surgery, participants will be monitored regularly to assess eye pressure control, need for glaucoma medications, surgical complications, and changes in bleb structure using imaging. Additional assessments include measurements of visual acuity, visual fields, and quality of life questionnaires. The main outcome is achieving target eye pressure without medications. This study provides detailed evaluation of both surgical techniques to inform future glaucoma care.

Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial