Anterior Segment Optical Coherence Tomography Microstent Positioning

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Glaucoma; Intraocular Pressure; Stent Dislodgement; Stent Migration

Treatments: Procedure: Cataract plus Microstent surgery

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06666751

163214

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

116 participants in 2 patient groups

Hydrus microstent

Description:

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

Treatment:

Procedure: Cataract plus Microstent surgery

iStent Inject

Description:

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

Treatment:

Procedure: Cataract plus Microstent surgery