The primary purpose of this study is to assess the efficacy of occlusion therapy (visual acuity of the amblyopic eye five weeks after cessation of occlusion therapy) in previously untreated patient with amblyopia between seven and forty years of age…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is visual acuity of the amblyopic eye five weeks
after cessation of occlusion therapy.
Secondary outcome
Secondary outcome parameters are cause of amblyopia, age at start occlusion
therapy, fixation, visual acuity of the amblyopic eye at start and end of
occlusion therapy, anisometropia, and aniseikonia.
Background summary
In about a third of patients, amblyopia persists in adulthood and thereby
increasing the risk of bilateral visual impairment due to loss of vision in the
nonamblyopic eye.
Amblyopia is commonly treated before age of six, but there is no agreement up
to which age amblyopia can be successful treated. Observations of improvement
in vision of the amblyopic eye following the loss of the good eye suggests that
upper age limit for response to amblyopia therapy may not be as rigid as
previously understood. The efficacy of occlusion therapy, thus, whether visual
improvement after occlusion therapy in older amblyopes remains or decreases
after occlusion is discontinued, is insufficiently investigated prospectively.
Study objective
The primary purpose of this study is to assess the efficacy of occlusion
therapy (visual acuity of the amblyopic eye five weeks after cessation of
occlusion therapy) in previously untreated patient with amblyopia between seven
and forty years of age. The secondary purposes are to determine factors, which
influence the stability of the response (visual acuity of the amblyopic eye
five weeks after cessation of occlusion therapy).
Study design
The study is designed as a prospective randomised crossover
investigator-initiated trial.
Intervention
Patients receive occlusion therapy (intervention) of the sound eye, three hours
per day/ seven days a week for 5 weeks and are instructed to perform near
visual activities while patching.
Study burden and risks
The risks involved in the study are identical to those that would be present
for a patient treated with the study treatment regimens who is not
participating in the study and pose no additional known risks. Skin irritation
due to patching or diplopia is unlikely in view of the small number of hours of
daily patching prescribed.
Lijnbaan 32
2501 CK Den Haag
Nederland
Lijnbaan 32
2501 CK Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
All patients between seven and forty years of age, diagnosed with amblyopia associated with strabismus and/ or anisometropia (anisometropia <= >1.0 D of spherical equivalent or >1.50 D difference in astigmatism in any meridian) will be eligible for the study.
Exclusion criteria
Previous treatment for amblyopia (includes occlusion, or pharmacological defocusing), previous optical correction of the amblyopic eye, ocular cause for reduced visual acuity, diminished acuity due to medication, brain damage, or trauma, neurological disorders, and eye muscle palsies.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18438.098.07 |