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

NCT ID: NCT07154810

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-16

Study Completion Date

2031-04-14

Brief Summary

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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?

Detailed Description

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Conditions

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Glaucoma Cataract Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bimatoprost Implant System / IOL Combination Low Dose

No interventions assigned to this group

Bimatoprost Implant System / IOL Combination Medium Dose

No interventions assigned to this group

Bimatoprost Implant System / IOL Combination High Dose

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Be able to understand a written informed consent and be willing to participate by evidence of signing an informed consent form

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SpyGlass Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sr. Director, Clinical Affairs

Role: STUDY_CHAIR

SpyGlass Pharma, Inc.

Locations

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Centro Oftalmológico Robles

Santa Rosa de Copán, , Honduras

Site Status

Countries

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Honduras

Other Identifiers

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SGP-SPEC-004

Identifier Type: -

Identifier Source: org_study_id

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