Invloed van klinische en sociaal-psychologische factoren op het effect van de afplakbehandeling bij patiŽnten met een niet behandeld lui oog tussen 12 en 40 jaar.|
|- candidate number||9011|
|- NTR Number||NTR2711|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jan-2011|
|- Secondary IDs||35519 ABR|
|- Public Title||Invloed van klinische en sociaal-psychologische factoren op het effect van de afplakbehandeling bij patiŽnten met een niet behandeld lui oog tussen 12 en 40 jaar.|
|- Scientific Title||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.
|- hypothesis||Efficacy of occlusion therapy initiated in patients with untreated amblyopia between twelve and forty years of age is effective.|
|- Healt Condition(s) or Problem(s) studied||Amblyopia, Efficacy, Occlusion therapy, Visual acuity|
|- 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;
3. Diminished acuity due to medication;
4. Brain damage, or trauma, neurological disorders, and eye muscle palsies;
5. Best corrected visual acuity in the amblyopic eye less than 1.3 LogMAR.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-jun-2013|
|- Target number of participants||44|
|- Interventions||All patients are prescribed three hours per day of part-time occlusion on the sound eye for a period of maximal 18 weeks. |
|- Primary outcome||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);|
2. Response rate of treatment of the amblyopic eye, improvement of at least two lines from start to end of occlusion therapy.
|- Secondary outcome||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. Clinical factors, which influence the treatment effect and the rate of recurrence.
By means of questionnaires: Evaluation and influence of the social-economic and ethic status and the psychosocial factors on compliance to occlusion therapy.
|- Timepoints||After the enrolment, each patient is prescribed optical correction (if needed). Patients are seen at 6 weeks intervals (within a time window of Ī1 week) up to 18 weeks (end of period of refractive adaptation).
After refractive adaptation, each patient will receive part-time occlusion on the sound eye until there is no further improvement (less than one LogMAR line) of visual acuity of the amblyopic eye, for a period of maximal 18 weeks. Patients are tested within 6 weeks intervals.
To determine the rate of recurrence following successful treatment (improvement of visual acuity at least two LogMAR lines from start to end of occlusion therapy) after treatment is discontinued, patients are continued in an observation phase for nine months. Follow-up visits take place three, six and nine months after discontinuation of treatment.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Brigitte Simonsz-Toth|
|- CONTACT for SCIENTIFIC QUERIES|| Brigitte Simonsz-Toth|
|- Sponsor/Initiator ||Medisch Centrum Haaglanden|
(Source(s) of Monetary or Material Support)
|Medisch Centrum Haaglanden|
|- Publications||Pediatric Eye Disease Investigator Group (2005) Randomized trial of treatment of amblyopia in children aged 7 to 17 years. Arch Ophthalmol, 123, 437-47.|
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.
Fronius, M., Bachert, I., LŁchtenberg, M. (2009) Electronic monitoring of occlusion treatment for amblyopia in patients aged 7 to 16 years. Graefes Arch Clin Exp Ophthalmol, 1401-8.
|- Brief summary||Amblyopia, defined as loss of visual function, caused by strabismus, anisometropia, and/or visual deprivation in the absence of ocular pathology, is commonly treated by occlusion therapy before age of six, limiting by the end of the sensitive period. However, recent studies suggest that the plasticity of the visual system extends into adolescents. In about a third of patients, 1% of the population, amblyopia persists in adulthood and thereby increasing the risk of bilateral visual impairment due to loss of vision in the nonamblyopic eye. This leads to decrease in quality of life and to increase costs to the healthcare system. The efficacy of occlusion therapy in adult patients, thus, whether visual improvement after treatment remains or decreases after occlusion is discontinued, is insufficiently investigated prospectively. Whether psychological factors or decreasing plasticity limits treatment effect in amblyopic adults is not clear.|
|- Main changes (audit trail)|
|- RECORD||24-jan-2011 - 6-jul-2011|
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