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The goal of this clinical trial is to further observe and learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also further observe and learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost Implant System / IOL Combination Low Dose | |||
| Bimatoprost Implant System / IOL Combination Medium Dose | |||
| Bimatoprost Implant System / IOL Combination High Dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline | The proportion of eyes that remain unmedicated and with an IOP reduction ≥ 20% from the SGP-SPEC-001 baseline visit for each follow-up time through the month 84 exam. | From Month 9 post-operative through the end of post-operative follow-up at Month 84 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in unmedicated IOP from SGP-SPEC-001 baseline visit for each follow-up time up to the month 84 exam. | From Month 9 post-operative through the end of post-operative follow-up at Month 84 | |
| Number of topical glaucoma medications used in the SGP-SPEC-001 screening for each follow-up time up to the month 84 examination |
Inclusion Criteria:
Exclusion Criteria:
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Ocular hypertension or open-angle glaucoma participants in Honduras who completed the SpyGlass Pharma Inc. SGP-SPEC-001 study.
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Director, Clinical Affairs | SpyGlass Pharma, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oftalmológico Robles | Santa Rosa de Copán | 41101 | Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41621045 | Derived | Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb;15(2):855-874. doi: 10.1007/s40123-026-01313-4. Epub 2026 Feb 1. |
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This is an observational extension to a proof of concept trial (first in human).
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| From Month 9 post-operative through the end of post-operative follow-up at Month 84 |
| Assessment of Postoperative Adverse Events | From Month 9 post-operative through the end of post-operative follow-up at Month 84 |
| Supplementary Safety Parameter - BCDVA | Best Corrected Distance Visual Acuity (snellen) | From Month 9 post-operative thorough the end of post-operative follow-up at Month 84 |
| Supplementary Safety Parameter - Slit Lamp Examination | Slit Lamp Examination Findings | From Month 9 post-operative thorough the end of post-operative follow-up at Month 84 |
| Supplementary Safety Parameter - Specular Microscopy | Endothelial Cell Density (cells per square millimeter) | Month 12 post-operative |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D002386 | Cataract |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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