GlaucomaNCT07154810
Observational Study to Evaluate Long Term Outcomes for Ocular Hypertension and Glaucoma Patients Treated With the SpyGlass Bimatoprost Implant System / IOL Combination
An observational study of Glaucoma and Cataract, run by SpyGlass Pharma, Inc. at 1 site in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Cataract, Ocular Hypertension
- How many people
- 23 participants
- Where
- 1 siteHonduras
- Study dates
- 16 Mar 2023to 14 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ocular hypertension or open-angle glaucoma participants in Honduras who completed the SpyGlass Pharma Inc. SGP-SPEC-001 study.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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?
- Conditions
- Glaucoma, Cataract, Ocular Hypertension
- Medical subject headings
- Glaucoma, Cataract, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bimatoprost Implant System / IOL Combination Low Dose | Not described | |
| Bimatoprost Implant System / IOL Combination Medium Dose | Not described | |
| Bimatoprost Implant System / IOL Combination High Dose | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Month 9 post-operative through the end of post-operative follow-up at Month 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start16 Mar 2023
- Primary completion14 Apr 2031 (estimated)
- Study completion14 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpyGlass Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Director, Clinical Affairs, Study chair, SpyGlass Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154810
- Sponsor's protocol ID
- SGP-SPEC-004
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational extension to a proof of concept trial (first in human).
Publications
Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb;15(2):855-874. doi: 10.1007/s40123-026-01313-4. Epub 2026 Feb 1.
PubMed 41621045
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07154810
- Acronym / sponsor ID
- SGP-SPEC-004
- Conditions
- Glaucoma, Cataract, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- SpyGlass Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 14 Apr 2031 (estimated)
- Study completion
- 14 Apr 2031 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bimatoprost Implant System / IOL Combination Low Dose | – | – |
| Bimatoprost Implant System / IOL Combination Medium Dose | – | – |
| Bimatoprost Implant System / IOL Combination High Dose | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ocular hypertension or open-angle glaucoma participants in Honduras who completed the SpyGlass Pharma Inc. SGP-SPEC-001 study.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 41621045Tan NE, Katz G, Robles M, Gupta PK, Kahook MY, Sussman G, Yoo P, Radcliffe NM. Prospective Pilot Study of Sustained Release Bimatoprost Implant with SpyGlass Intraocular Lens: 3-Year Results. Ophthalmol Ther. 2026 Feb;15(2):855-874. doi: 10.1007/s40123-026-01313-4. Epub 2026 Feb 1.
- Individual participant dataSharing planned: No. This is an observational extension to a proof of concept trial (first in human).
Related trials for Glaucoma
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PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sr. Director, Clinical Affairs study chair
SpyGlass Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Cataract, run by SpyGlass Pharma, Inc. at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07154810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.