Invloed van klinische en sociaal-psychologische factoren op het effect van de afplakbehandeling bij patiënten met een niet behandeld lui oog tussen 12 en 40 jaar.

Registration Number: NL-OMON26407

Lead Sponsor: Medisch Centrum Haaglanden Den Haag, locatie Westeinde

Brief Summary: Pediatric Eye Disease Investigator Group (2005) Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol, 123, 437-47.<br> Loudon, SE., Passchier, J., Chaker, L., de Vos, S., Fronius, M., Harrad, RA., Looman, CW., Simonsz, B., Simonsz, HJ. (2009) Psychological causes of non-compliance with electronically monitored occlusion therapy for amblyopia. Br J Ophthalmol, 93(11), 1499-503.<br> Fronius, M., Bachert, I., Lüchtenberg, M. (2009) Electronic monitoring of occlusion treatment for amblyopia in patients aged 7 to 16 years. Graefes Arch Clin Exp Ophthalmol, 1401-8.

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

1. All patients between twelve and forty years of age, diagnosed with amblyopia associated with strabismus and/ or anisometropia (>1.0 D of spherical equivalent or >1.50 D difference in astigmatism in any meridian);

2. Visual acuity in the amblyopic eye at least 1.3 LogMAR, using best correction based on the results of a cycloplegic refraction performed within past two months.

Exclusion Criteria

1. Previous treatment for amblyopia (includes occlusion, or pharmacological defocusing);

2. Ocular cause for reduced visual acuity;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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