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

SpyGlass Pharma, Inc.

Status: Active, not recruiting

Conditions: Cataract; Glaucoma; Ocular Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT07154810

SGP-SPEC-004

Details and patient eligibility

About

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?

Enrollment: 23 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 3 patient groups

Bimatoprost Implant System / IOL Combination Low Dose

Bimatoprost Implant System / IOL Combination Medium Dose

Bimatoprost Implant System / IOL Combination High Dose