Clinical trial NCT06666751: Anterior Segment Optical Coherence Tomography Microstent Positioning
Official title: Post-operative Anterior Segment OCT Evaluation of Trabecular Microstent Positioning and the Impact on Intraocular Pressure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Stent Migration
Stent Dislodgement
Intraocular Pressure
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-10-31
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups
timeFrame: Two years post stent placement
Secondary outcomes:
measure: Dilation of Schlemm's canal
timeFrame: Two years post stent placement
measure: Change in IOP from baseline
timeFrame: Two years post stent placement
measure: Reduction in number of IOP lowering medications
timeFrame: Two years post stent placement
measure: Percentage of patients needing additional glaucoma surgery
timeFrame: Two years post stent placement
measure: Sub-analysis of primary outcome by surgeon type
timeFrame: Two years post stent placement
measure: Proportion of stent cases with proper placement via anterior segment OCT versus proportion of cases with proper placement via intraoperative gonioscopy
timeFrame: Two years post stent placement
Other outcomes:
Locations:
city: Murray
country: United States
facility: Moran Eye Center
state: Utah
Study officials:
affiliation: Moran Eye Center
name: Rachel Simpson, MD
role: PRINCIPAL_INVESTIGATOR
References: