GlaucomaNCT06666751
Anterior Segment Optical Coherence Tomography Microstent Positioning
An observational study of Glaucoma and Stent Migration, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glaucoma, Stent Migration, Stent Dislodgement
- What is being tested?
- Cataract plus Microstent surgery
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2024to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Any adult glaucoma patient (age 18+) who underwent Hydrus microstent or iStent Inject placement at the Moran Eye Center.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Anterior Segment OCT Evaluation of Trabecular Microstent Positioning and the Impact on Intraocular Pressure
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?
Read more
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.
- Conditions
- Glaucoma, Stent Migration, Stent Dislodgement, Intraocular Pressure
- Being tested
- Cataract plus Microstent surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract plus Microstent surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrus microstent | Participants in this group underwent Hydrus microstent placement at the Moran Eye Center. Receives: Procedure: Cataract plus Microstent surgery | |
| iStent Inject | Participants in this group underwent iStent Inject placement at the Moran Eye Center. Receives: Procedure: Cataract plus Microstent surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years post stent placement
Secondary outcomes (6)
Dilation of Schlemm's canal
The Schlemm's canal is a circular lymphatic-like vessel in the eye that maintains fluid homeostasis by draining aqueous humor from the eye into the systemic circulation. If the canal is blocked, the pressure in the eye can increase, resulting in glaucoma. Dilation will be visualized on OCT and graded on a numerical scale 1-3 (1=dilated, 2=some dilation, 3=no dilation) at the one-time study visit.
Measured: Two years post stent placement
Change in IOP from baseline
IOP is measured in millimeters of mercury (mmHg). A retrospective chart review will be conducted to acquire 2-year data to determine the change in each participant's IOP from baseline. The between group difference of change in IOP will be calculated in percentage.
Measured: Two years post stent placement
Reduction in number of IOP lowering medications
A retrospective chart review will be conducted to determine how many IOP lowering medications each patient is using at 2 years post-stent placement compared to the number of IOP lowering medications they were using prior to stent placement. The between group difference of reduction in number of medications will be calculated in percentage.
Measured: Two years post stent placement
Percentage of patients needing additional glaucoma surgery
A retrospective chart review will be conducted to determine the percentage of patients who had additional glaucoma surgery by the two-year post stent placement timepoint. The between group difference in number of patients needing additional glaucoma surgery will be calculated in percentage.
Measured: Two years post stent placement
Sub-analysis of primary outcome by surgeon type
There will be a sub-analysis of the percentage of mispositions (primary endpoint) by level of surgeon experience. A retrospective chart review of the intraoperative note will determine if the primary surgeon was a resident or non-resident (attending or fellow).
Measured: 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
The intraoperative notes at the time of stent placement will include confirmation of proper stent placement via gonioscopy. At the time of the study visit, stent placement will be assessed via anterior segment OCT. The number of correctly positioned stent placements will be reported in percentages.
Measured: Two years post stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start9 Apr 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Rachel Simpson, University of Utah
- Investigators
- Rachel Simpson, MD, Principal investigator, Moran Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666751
- Sponsor's protocol ID
- 163214
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Anterior Segment OCT Evaluation of Trabecular Microstent Positioning and the Impact on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT06666751
- Acronym / sponsor ID
- 163214
- Conditions
- Glaucoma, Stent Migration, Stent Dislodgement, Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrus microstent | – | Procedure: Cataract plus Microstent surgeryParticipants in this group underwent Hydrus microstent placement at the Moran Eye Center. |
| iStent Inject | – | Procedure: Cataract plus Microstent surgeryParticipants in this group underwent iStent Inject placement at the Moran Eye Center. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Any adult glaucoma patient (age 18+) who underwent Hydrus microstent or iStent Inject placement at the Moran Eye Center.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cataract plus Microstent surgeryBoth 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. | Procedure or surgery | Hydrus microstent, iStent Inject |
Primary outcome
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.
6 secondary outcomes
Dilation of Schlemm's canal
Time frame: Two years post stent placement
Change in IOP from baseline
Time frame: Two years post stent placement
Reduction in number of IOP lowering medications
Time frame: Two years post stent placement
Percentage of patients needing additional glaucoma surgery
Time frame: Two years post stent placement
Sub-analysis of primary outcome by surgeon type
Time frame: 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
Time frame: Two years post stent placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Glaucoma
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Simpson, MD principal investigator
Moran Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Stent Migration, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups (time frame: Two years post stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.