Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Inclusion Criteria:

• age 18 to 85
• open-angle glaucoma uncontrolled medically
• intraocular pressure ≥ 18 mmHg
• trabeculectomy as the planned surgical procedure

Exclusion Criteria:

• any previous ocular incisional surgery with the exception of previous clear
• cornea cataract surgery
• uveitis
• vitreous present in anterior chamber
• patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits