Evaluation of FAVAS ( Focal ambient visual acuity stimulation) digital based health applicatio

Recruiting

• Conditions: H53.0; Amblyopia ex anopsia

• Registration Number: DRKS00030216
• Lead Sponsor: Caterna Vision GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

Study indications according to ICD-10: H53.0 - Amblyopia ex anopsia
- Medical diagnosis of amblyopia with visual acuity difference of the eyes > 0.1 log MAR or visual acuity < 0.1 log MAR in the worse eye
- Refractive amblyopia
- Strabismic ambyopia
- Refractive and strabismic ambylopia
- Age 4-12 years
- Prescribed occlusion therapy with stagnant visual development under occlusion before application of the intervention/control
- 90-day use of the intervention/control

Exclusion Criteria

- Patients with proven learning disabilities
- Patients with
Deprivation amblyopia
Other ophthalmological pre-existing conditions such as cataracts, corneal, lens and retinal anomalies
Other pre-existing conditions that can negatively affect an independent visual prognosis
Epilepsy (G40)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of the study is to prove that in patients who have already completed an initial standard occlusion and have a stagnant visual acuity, the subsequent 90-day use of the combination therapy of occlusion and stimulation therapy (intervention) is superior to the sole further application of the standard treatment of occlusion (control) with regard to visual development according to subjective refraction with row optotypes.

Secondary Outcome Measures

Name	Time	Method
Improvement in stereo vision<br>