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NCT Number: NCT07154810

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Oftalmológico Robles

Santa Rosa de Copán, 41101, Honduras

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline

    Time frame: 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 outcomes

  1. Mean change in unmedicated IOP from SGP-SPEC-001 baseline visit for each follow-up time up to the month 84 exam.

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

  2. Number of topical glaucoma medications used in the SGP-SPEC-001 screening for each follow-up time up to the month 84 examination

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

  3. Assessment of Postoperative Adverse Events

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

  4. Supplementary Safety Parameter - BCDVA

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

    Best Corrected Distance Visual Acuity (snellen)

  5. Supplementary Safety Parameter - Slit Lamp Examination

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

    Slit Lamp Examination Findings

  6. Supplementary Safety Parameter - Specular Microscopy

    Time frame: Month 12 post-operative

    Endothelial Cell Density (cells per square millimeter)

Sponsors and collaborators

Lead sponsor

SpyGlass Pharma, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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