Observational Study to Evaluate Long Term Outcomes for Ocular Hypertension and Glaucoma Patients Treated With the SpyGlass Bimatoprost Implant System / IOL Combination

N/AActive Not RecruitingNCT07154810

SpyGlass Pharma, Inc.23 enrolled

Overview

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: * Does the Bimatoprost Implant System / IOL Combination continue lower the pressure inside the eye to treat ocular hypertension or glaucoma long term? * Does the Bimatoprost Implant System / IOL Combination continue to correct vision after cataract surgery long term? * What long term medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination?

Study Type

OBSERVATIONAL

Enrollment

Conditions

Glaucoma Cataract Ocular Hypertension

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Be able to understand a written informed consent and be willing to participate by evidence of signing an informed consent form * Met all inclusion criteria, participated in and completed the SGP-SPEC-001 study Exclusion Criteria: * Planned participation in another clinical trial within 30 days of the initial study visit that, in the investigator's opinion, could confound the study results

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: From Month 9 post-operative through the end of post-operative follow-up at Month 84