N/A
N=120
Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00444080 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Postoperative Intraocular Pressure — 14.6; 14.7 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trabeculectomy (Procedure); Ex-PRESS mini shunt (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Intraocular Pressure |
14.6; 14.7 | — |
| PRIMARY Medications |
0.7; 0.9 | — |
| SECONDARY Safety - Incidence of Adverse Events |
25; 11 | 0.013 sig |
| SECONDARY Efficacy - The Number of Participants With Qualified and Complete Success |
48; 49 | — |
Summary
A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.
Eligibility Criteria
Inclusion Criteria
- Adult subject over the age of 18
- Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
- Subject is a candidate for filtering surgery with intraoperative anti-metabolites
- IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
- Subject willing to attend all follow-up evaluations
- Subject willing to sign informed consent.
Exclusion Criteria
- Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
- Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
- Subject has history of penetrating keratoplasty (PKP)
- Subject underwent large incision extra capsular cataract extraction
- Subject had cataract phacoemulsification within the last month
- Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
- Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
- Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
- IOP of ≤18mmHg
- Subject participates in any other concurrent ocular investigation.
Data sourced from ClinicalTrials.gov (NCT00444080). 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.