NCT06666751

Anterior Segment Optical Coherence Tomography Microstent Positioning

Post-operative Anterior Segment OCT Evaluation of Trabecular Microstent Positioning and the Impact on Intraocular Pressure

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 116 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Glaucoma
• Stent Migration
• Stent Dislodgement
• Intraocular Pressure

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2024-04-09
• Primary completion: 2027-04-30
• Completion: 2027-05-30
• First posted: 2024-10-31
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States