Post-operative Anterior Segment OCT Evaluation of Trabecular Microstent Positioning and the Impact on Intraocular Pressure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups
Study Overview
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:
- How often are microstents mispositioned?
- 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:
- Surgeon type and level of experience (resident, fellow, attending ophthalmologist)
- Proportions of proper gonioscopic placement intraoperatively for each surgeon group
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups
Time Frame: Two years post stent placement
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.
Secondary Outcomes
- 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)
- Proportion of stent cases with proper placement via anterior segment OCT versus proportion of cases with proper placement via intraoperative gonioscopy(Two years post stent placement)
Investigators
Rachel Simpson
Assistant Professor (Clinical)
University of Utah