Anterior Segment Optical Coherence Tomography Microstent Positioning

NCT06666751 | Active Not Recruiting

• 1 other identifier: 163214
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.How often are microstents mispositioned?
2. 2.What effect does microstent positioning have on intraocular pressure after surgery?
3. 3.Surgeon type and level of experience (resident, fellow, attending ophthalmologist)
4. 4.Proportions of proper gonioscopic placement intraoperatively for each surgeon group
5. 5.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.

Conditions

Glaucoma; Stent Migration; Stent Dislodgement; Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups

  Positioning of each participant's stent(s) will be evaluated by anterior segment OCT at the one-time clinical study visit. iStent Inject W mispositions are defined as: microstent protrusion (entire conical head not within canal), stent completely buried in the trabeculae, or not seen (i.e. 0 or only 1 stent). If the iStent position is located but the examiner is unsure if it is positioned correctly, it will be counted as misposition. If the iStent is not seen, an in office gonioscopy will be performed to confirm results. Visualization of three stents is not considered a misposition. Hydrus mispositions are defined as: distal tip not in canal, at least 1 window not in canal, or trabecular microstent not within transition zone. The between group difference of mispositioned stents will be calculated in percentage.

  Two years post stent placement

Secondary Outcomes (6)

• Dilation of Schlemm's canal

  Two years post stent placement

• Change in IOP from baseline

  Two years post stent placement

• Reduction in number of IOP lowering medications

  Two years post stent placement

• Percentage of patients needing additional glaucoma surgery

  Two years post stent placement

• Sub-analysis of primary outcome by surgeon type

  Two years post stent placement

Study Arms (2)

Hydrus microstent

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

Procedure: Cataract plus Microstent surgery

iStent Inject

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

Procedure: Cataract plus Microstent surgery

Interventions

Cataract plus Microstent surgery 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.

Hydrus microstent; iStent Inject

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comes from the Moran Eye Center, which is part of an academic teaching hospital and includes multiple community clinic locations.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Alcon Research: collaborator

Study Sites (1)

Moran Eye Center

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Rachel Simpson, MD

  Moran Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 31, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)