Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

University of Toronto

Status

Completed

Conditions

Glaucoma

Treatments

Procedure: trabeculectomy

Procedure: ExPRESS shunt

Study type

Interventional

Funder types

Other

Identifiers

NCT01263561

07-0888-A

Details and patient eligibility

About

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.

Full description

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.

Enrollment

64 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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