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

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 - Efficacy of occlusion therapy (EOT2 )

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35897

Enrollment

Registered

2011-07-06

Start date

2011-12-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia lazy eye

Interventions

All participants were prescribed three hours per day of part-time occlusion on the sound eye for a period of maximal 4 months.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 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. 3) By means of questionnaires: Evaluation and influence of the social-economic and ethic status and the psychosocial factors on compliance to occlusion therapy.	—

Measure

Time frame

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 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. 3) By means of questionnaires: Evaluation and influence of the social-economic and ethic status and the psychosocial factors on compliance to occlusion therapy.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)