Status:
COMPLETED
Evaluation of the Safety and Effectiveness of the Bimatoprost Implant System / IOL Combination in Patients With Ocular Hypertension or Mild to Moderate Open-angle Glaucoma
Lead Sponsor:
SpyGlass Pharma, Inc.
Conditions:
Cataract
Ocular Hypertension
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn ...
Detailed Description
This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Parti...
Eligibility Criteria
Inclusion
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
- Planned removal of cataract
- Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
Exclusion
- Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening
- History of incisional/refractive corneal surgery
- Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders
- Other ocular diseases, pathology, or conditions
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07154797
Start Date
April 21 2022
End Date
December 13 2022
Last Update
September 4 2025
Active Locations (1)
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1
Centro Oftalmológico Robles
Santa Rosa de Copán, Honduras, 41101