Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Glaucoma Clinical Trial

Official title:

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263561
• Other study ID #: 07-0888-A
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: December 7, 2014
• Start date: April 2009
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• ExPRESS shunt
ExPRESS miniature glaucoma drainage device
• trabeculectomy
trabeculectomy filtering surgery

Locations

Country	Name	City	State
Canada	Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure		1 year post surgery	No
Primary	Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication		1 year post surgery	No
Secondary	Complications	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.	1 year post surgery	Yes