Home testing devices for managing glaucoma

Evaluating Effectiveness of Home Testing Devises for Assisting in Management of Glaucoma Outside a Clinical Setting During a 2 Year Period.

This study is testing if using home devices to check eye pressure and vision can help people with glaucoma manage their condition better than traditional office visits.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Wills Eye (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT05325996 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility and patient acceptance of using home testing devices for glaucoma management, specifically focusing on head mounted perimetry and portable tonometry. Participants will use the VisuALL head mounted perimeter to monitor their visual field and an iCare Home Tonometer to measure eye pressure at home. The study aims to compare the effectiveness of these home devices against traditional office-based testing methods. By enabling patients to conduct tests in a comfortable setting, the study seeks to improve monitoring and early detection of glaucoma progression.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 20-80 with mild to moderate open-angle glaucoma and specific refractive error criteria.

Not a fit: Patients with severe visual impairment, recent ocular surgeries, or other conditions affecting visual function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance patient autonomy and improve early detection of glaucoma progression, leading to better management of the condition.

How similar studies have performed: While the use of home testing devices for glaucoma is an emerging field, previous studies have shown promise in similar approaches, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age 20-80 years
2. Mild and Moderate Open Angle Glaucoma (OAG)
3. Refraction under 12.00 diopter of spherical refractive error and astigmatism of less than 2.5 diopter.

Exclusion Criteria:

1. Spherical refraction outside \> ± 12.00 D and cylinder correction \> +2.5 D.
2. Visual acuity worse than 20/50 either eye
3. Cataract surgery with or without Minimally Invasive Glaucoma Surgery (MIGS) less than 90 days prior to enrollment
4. Filtering surgeries less than 6 months prior to enrollment
5. Intraocular surgery other than:

   1. Non-complicated MIGS more than 90 days prior to enrollment;
   2. Cataract or refractive surgery performed more than 90 days before enrollment and without posterior capsule opacification
   3. Other glaucoma surgery more than 6 months prior to enrollment.
6. History of systemic or ocular condition (other than glaucoma or mild to moderate cataract) known to affect visual function.
7. History of medication known to affect visual function or influence patient reaction time
8. Inability to use device after remote training session
9. Subjects unwilling and/or unable to participate

Where this trial is running

Philadelphia, Pennsylvania

• Wills Eye Hospital — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: M. Reza Razeghinejad, MD — Wills Eye Hospital
• Study coordinator: Jeanne L Molineaux, COA

Conditions Glaucoma, Open-Angle; Open Angle Glaucoma; Perimetery; Tonometry; Eye Pressure; Visual Field; Home Test