N/A
N=64
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01263561 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Intraocular Pressure — 10.7; 11.2 mmHg — p=.85
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ExPRESS shunt (Procedure); trabeculectomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Toronto
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
10.7; 11.2 | .85 |
| PRIMARY Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication |
57; 71 | .24 |
| SECONDARY Complications |
12; 13; 2; 3; 1; 0 | 0.80 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01263561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.