Clinical and psychosocial determinants influencing treatment effect of occlusion therapy and rate of recurrence in previously untreated patients with amblyopia between 12 and 40 years of age

Completed

• Conditions: Amblyopia; lazy eye; 10047518

• Registration Number: NL-OMON35897
• Lead Sponsor: Medisch Centrum Haaglanden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

-Patients between twelve and forty years of age, diagnosed with untreated amblyopia associated with strabismus and/ or anisometropia
-Visual acuity in the amblyopic eye at least 1.0 logMAR (logarithm of the minimum angle of resolution) using best correction based on the results of a cycloplegic refraction

Exclusion Criteria

Previous treatment for amblyopia (occlusion therapy, atropinisation, penalisation), reduced visual acuity due to ocular cause or medication, brain damage, or trauma, neurological disorders, and eye muscle palsies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameter:<br /><br>1) Improvement of visual acuity in logMAR, from best-corrected visual acuity<br /><br>(after refractive adaptation) of the amblyopic eye at start occlusion therapy<br /><br>to visual acuity at the end of occlusion therapy (maximal treatment effect).<br /><br>2) Response rate of treatment of the amblyopic eye, improvement of at least two<br /><br>lines from start to end of occlusion therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Rate of recurrence: Measurement of visual acuity in logMAR of the amblyopic<br /><br>eye nine months after cessation of treatment at least two lines worse than<br /><br>visual acuity at end of occlusion therapy<br /><br>2) Refractive adaptation: Visual acuity in logMAR, uncorrected visual acuity of<br /><br>the amblyopic eye to 18 weeks after prescription of optical correction, as a<br /><br>function of age, type of amblyopia, and refractive error.<br /><br>3) By means of questionnaires: Evaluation and influence of the social-economic<br /><br>and ethic status and the psychosocial factors on compliance to occlusion<br /><br>therapy. </p><br>