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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201208000401104

Enrollment

Registered

2012-07-26

Start date

2011-10-17

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma surgical intervention

Interventions

Express Mini shunt (EMS) insertion

Trabeculectomy with mitomycin C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The mean intraocular pressure compared between treatment groups	—

Secondary

Measure	Time frame
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	—

Countries

Kenya

Contacts

Public ContactRodgers Mieno

Study Coordinator

rodgers_enrique@yahoo.com+254 724 291 669

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026