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The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSPI | Experimental | Molteno single-plate implant |
|
| AVI | Active Comparator | Ahmed valve implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ahmed valve implant | Device | 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra Ocular pressure (IOP) | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Intra Ocular pressure (IOP) | day 1,week 1, and months 1, 3, 6, 9, 12 and 18 | |
| Changes in visual acuity | day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24. | |
| Number of anti-glaucoma medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nader Nassiri, MD | Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran | Principal Investigator |
| Nariman Nassiri, MD | Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran | Principal Investigator |
| Ghazal Kamali, MD | 4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanak Eye Surgery Center | Tehran | Tehran Province | Iran |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Molteno single-plate implant (MSPI) | Device | 134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand) |
|
| week 1, and months 1, 3, 6, 9, 12, 18, and 24 |
| Mean deviation of visual field, | week 1, and months 1, 3, 6, 9, 12, 18, and 24 |
| Rate of intra- and postoperative complications | week 1, and months 1, 3, 6, 9, 12, 18, and 24 |