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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrus microstent | Participants in this group underwent Hydrus microstent placement at the Moran Eye Center. |
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| iStent Inject | Participants in this group underwent iStent Inject placement at the Moran Eye Center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataract plus Microstent surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two years post stent placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comes from the Moran Eye Center, which is part of an academic teaching hospital and includes multiple community clinic locations.
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Simpson, MD | Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moran Eye Center | Murray | Utah | 84107 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 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. | 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. | 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. | 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). | 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. | Two years post stent placement |