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Inadequate recruitment
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This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant.
A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).
Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Baerveldt 250 mm2 | Experimental | Patients receiving Baerveldt 250 mm2 |
|
| Arm B - Baerveldt 350 mm2 | Experimental | Patients receiving Baerveldt 350 mm2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baerveldt Device surgical Procedure | Procedure | Implant surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) | Visual acuity is an important outcome variable in the BPAC. Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing will be employed at the Qualifying Assessment and at every follow-up visit.The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Boland, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Davis | Sacramento | California | 95817-2307 | United States | ||
| U. Miami/Bascom Palmer |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Miami |
| Florida |
| 33136 |
| United States |
| The Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Wills Eye Institute | Philadelphia | Pennsylvania | United States |