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

Observational Study to Evaluate Long-term Follow-up of Subjects Implanted With Sustained-release Bimatoprost With the SpyGlass IOL in Subjects With Ocular Hypertension or Mild-to-moderate Open-angle Glaucoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07154810

Enrollment

Registered

2025-09-04

Start date

2023-03-16

Completion date

2031-04-14

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma, Ocular Hypertension

Brief summary

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?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline	From Month 9 post-operative through the end of post-operative follow-up at Month 84	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.

Other

Measure	Time frame	Description
Number of topical glaucoma medications used in the SGP-SPEC-001 screening for each follow-up time up to the month 84 examination	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	—
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	—
Supplementary Safety Parameter - Slit Lamp Examination	From Month 9 post-operative thorough the end of post-operative follow-up at Month 84	Slit Lamp Examination Findings
Supplementary Safety Parameter - Specular Microscopy	Month 12 post-operative	Endothelial Cell Density (cells per square millimeter)
Supplementary Safety Parameter - BCDVA	From Month 9 post-operative thorough the end of post-operative follow-up at Month 84	Best Corrected Distance Visual Acuity (snellen)

Countries

Honduras

Outcome results