A study aiming at showing the performance and safety of the Eagle device by collecting data from patients being treated for glaucoma or eye hypertension with the Eagle device

Not Applicable

• Conditions: Glaucoma and ocular hypertension; Eye Diseases

• Registration Number: ISRCTN16769682
• Lead Sponsor: BELKIN Vision Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 12 August 2024
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

1. Adult participants who underwent treatment with the Eagle device for treatment of Open Angle Glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension as per the approved indication.
2. Participants with expected post-operative follow-up data of at least six (6) months

Exclusion Criteria

Records of participants with any of the following conditions at the date of the treatment with the Eagle device, will not be included in the data collection:
1. Participants who are unable to fixate their head and/or eyes, such as participants suffering from nystagmus, tremors or similar conditions.
2. Participants with congenital glaucoma or active anterior segment inflammations.
3. Participants with any condition that obscures the limbus, such as melanosis affecting the limbus, severe arcus senilis affecting the limbus, pterygium affecting the limbus or any other such conditions.
4. Participants with any condition that causes poor visualization of the limbus that prevents the Eagle device’s treatment target identification.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP) measured using data collected in medical records at the standard of care timepoint within the 4-8 months post-treatment interval following the direct selective laser trabeculoplasty treatment

Secondary Outcome Measures

Name	Time	Method
1. Performance of the device measured using data collected in patient medical records associated with the evaluation of IOP, potential post-treatment surgical intervention, retreatments with the Eagle device and ocular medication of the participant after treatment at the study end<br>2. Device safety measured using data collected in patient medical records associated with the rate of adverse device effects and device deficiencies at the study end<br>3. The usability for the practician measured using a bespoke questionnaire at the direct selective laser trabeculoplasty (DSLT) procedure visit <br>4. Patient experience measured using a bespoke questionnaire at the DSLT procedure visit