THE Ex-PRESS MINI SHUNT VERSUS TRABECULECTOMY IN AFRICAN PATIENTS: A RANDOMIZED CONTROLLED TRIA

Not Applicable

Recruiting

• Conditions: Glaucoma surgical intervention

• Registration Number: PACTR201208000401104
• Lead Sponsor: ALCON LABORATORIES INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age 18 to 90 years, inclusive.
Glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure > 18 mm Hg and < 40mm Hg.
Glaucoma drainage surgery as planned surgical procedure.
Primary Open Angle Glaucoma or pseudoexfoliative glaucoma.
Black African ethnicity.

Exclusion Criteria

Unwilling or unable to give consent or unwilling to accept randomization.
Inability to attend follow-up visits
Visual acuity of ¿no light perception¿ (NLP).
Previous filtering or cyclodestructive procedure in the same eye.
Previous ocular procedure involving the conjunctiva e.g. vitrectomy, scleral buckling, cyclodestructive procedure.
Previous cataract extraction (phacoemulsification, small incision cataract surgery, extra capsular cataract extraction).
Conjunctival scarring precluding trabeculectomy superiorly.
Aphakia.
Any secondary cause of glaucoma.
Angle closure glaucoma.
Need for glaucoma surgery combined with other ocular procedures e.g cataract extraction, penetrating keratoplasty, retinal surgery.
Active proliferative diabetic retinopathy and/or active iris neovascularisation.
Pregnant or nursing women
Unwilling to discontinue contact lens use after surgery.
Chronic or recurrent uveitis.
Severe posterior blepharitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean intraocular pressure compared between treatment groups

Secondary Outcome Measures

Name	Time	Method
Comparison of surgical complications between the 2 groups;Comparison of patients achieving complete success, qualified success, or failure in each group.;Number of additional surgical procedures in each group;Change in visual acuity over time;Change in glaucoma medication over time;Difference in bleb appearanc eover time between the 2 groups