N/A
Completed N=238
The AVB Study: Prospective Study Comparing the Ahmed Valve and the Baerveldt Implant for Treating Refractory Glaucoma
Source: ClinicalTrials.gov NCT00940823 ↗Enrolled (actual)
238
Serious AEs
13.9%
Results posted
Mar 2018
Primary outcomePrimary: Number of Participants With Surgical Failure (Composite Measure) — 63; 40 participants
Summary
The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from multiple study centers and randomized to a glaucoma drainage device for implantation. They will be followed long-term based upon outcome measures including intraocular pressure, glaucoma medication use, visual acuity, complications of the surgery and further treatments required.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgical Failure (Composite Measure) |
63; 40 | — |
| SECONDARY Intraocular Pressure (IOP) |
16.6; 13.6 | — |
| SECONDARY Anti-glaucoma Medications |
1.8; 1.2 | — |
| SECONDARY LogMAR Snellen Visual Acuity |
1.6; 1.6 | — |
| SECONDARY Number of Participants With Complications During or After Surgery |
78; 79 | — |
| SECONDARY Number of Participants With Interventions After Surgery |
64; 58 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 18.
- Inadequately controlled glaucoma determined as intraocular pressure (IOP) greater than target, which has not responded to conventional medical and surgical therapy.
- Patients with significant conjunctival scarring or high-risk disease (active neovascular glaucoma) precluding antimetabolite trabeculectomy will be included in the study.
- Provide written informed consent to participate in the study.
Exclusion Criteria
- Age less than 18.
- Patient will undergo an additional procedure at the time of glaucoma drainage device implantation (i.e. lensectomy, penetrating keratoplasty)
- No light perception vision.
- Patient has already been enrolled in the study in the contralateral eye.
- Patient is unwilling or unable to provide informed consent to participate in the study, or adhere to the study requirements including implant randomization and required follow-up visits.
Data sourced from ClinicalTrials.gov (NCT00940823). 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. Informational only — not medical advice.