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Study aim:
To compare the effect of Cambridge vision stimulator (CAM) therapy with passive occlusion therapy in the management of unilateral amblyopia.
Design:
Clinical trial with control group, with parallel groups, randomized, phase 2 on 100 patients. A flipping-coin is used for randomization.
Settings and conduct:
All participants will be recruited from first diagnosed unilateral amblyopic children referred to the eye center for managing amblyopia in Ruaa optometry clinic, Najaf, Iraq. The main provision of the study will be recruiting those patients who have not been previously received any amblyopia treatment modality.
We will record the pre-and post-amblyopia treatment data of patients who will have been followed for three months after CAM therapy and passive occlusion therapy. At the first stage, all selected candidates whose amblyopia has not been managed previously will be corrected. The collected data during the baseline and follow-up examination sessions are included demographic characteristics, uncorrected and corrected distance visual acuity (UDVA and CDVA) using a standard Snellen chart within a 6-meter distance, spherical objective cyclo-refraction.
Participants/Inclusion and exclusion criteria:
- Inclusion criteria
Children between 4-10-year-old; Patients with unilateral functional amblyopia (due to anisometropia and/or strabismus); Patients who will be newly diagnosed with amblyopia and will be received their first management strategy; Patients with CDVA worse than 0.8 (20/25)
- Exclusion criteria
Patients with organic amblyopia; Presence of systemic diseases affecting ocular anatomy and function; Patients with a history of amblyopia management and strabismus surgery; Children a premature birth
Intervention groups:
Amblyopia treatment by painting on CAM device and occlusion therapy group
Main outcome variables:
Uncorrected and best-corrected visual acuity