Anterior Segment Optical Coherence Tomography Microstent Positioning

NCT ID: NCT06666751

Last Updated: 2024-10-31

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

RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-09

Study Completion Date

2027-05-30

Brief Summary

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The goal of this observational study is to learn about the long-term results of glaucoma stent surgery in men and women 18 or older who have had cataract and microstent surgery in the past 2 years at the Moran Eye Center. The main questions the study aims to answer are:

1. How often are microstents mispositioned?
2. What effect does microstent positioning have on intraocular pressure after surgery?

Participants will have a one-time clinic visit for an eye exam and Optical Coherence Tomography (OCT) .

From the eye exam and OCT, Researchers will assess and categorize the position of the microstents and assess the Schlemm's canal dilation.

Researchers will review the participants' medical records to acquire 2-year data for the following:

1. Surgeon type and level of experience (resident, fellow, attending ophthalmologist)
2. Proportions of proper gonioscopic placement intraoperatively for each surgeon group
3. Effectiveness of surgery, based on change in intraocular pressure (IOP) from baseline medicated IOP, number of IOP-lowering medications the patient was able to discontinue, and rate of need for additional glaucoma surgery.

Detailed Description

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Conditions

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Glaucoma Stent Migration Stent Dislodgement Intraocular Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hydrus microstent

Participants in this group underwent Hydrus microstent placement at the Moran Eye Center.

Cataract plus Microstent surgery

Intervention Type PROCEDURE

Both the Hydrus microstent and iStent Inject W are used in combination with cataract surgery, in order to help lower intraocular pressure for patients with open-angle glaucoma. The microstent is a small flexible device that is inserted into the eye during cataract surgery in order to improve the outflow of fluid from the eye.

iStent Inject

Participants in this group underwent iStent Inject placement at the Moran Eye Center.

Cataract plus Microstent surgery

Intervention Type PROCEDURE

Both the Hydrus microstent and iStent Inject W are used in combination with cataract surgery, in order to help lower intraocular pressure for patients with open-angle glaucoma. The microstent is a small flexible device that is inserted into the eye during cataract surgery in order to improve the outflow of fluid from the eye.

Interventions

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Cataract plus Microstent surgery

Both the Hydrus microstent and iStent Inject W are used in combination with cataract surgery, in order to help lower intraocular pressure for patients with open-angle glaucoma. The microstent is a small flexible device that is inserted into the eye during cataract surgery in order to improve the outflow of fluid from the eye.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Any adult glaucoma patient (age 18+) who underwent Hydrus microstent or iStent Inject placement at the Moran Eye Center.

Exclusion Criteria

* Any patient who subsequently had to have their stent removed for any reason, any patient with a history of trauma to the anterior segment or reconstruction altering typical anatomy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Rachel Simpson

Assistant Professor (Clinical)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

Moran Eye Center

Locations

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Moran Eye Center

Murray, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rachel Simpson, MD

Role: CONTACT

480-388-9038

Facility Contacts

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Rachel Simpson, MD

Role: primary

801-581-2955

Other Identifiers

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163214

Identifier Type: -

Identifier Source: org_study_id

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