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Comparison of CAM and Sham CAM in Pediatric Unilateral Amblyopia

Comparison of Cambridge Vision Stimulator (CAM) Therapy with Sham CAM Therapy in Patients with Unilateral Functional Amblyopia: A Randomized Clinical Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120723010364N4
Enrollment
132
Registered
2026-01-13
Start date
2025-10-23
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Unilateral Functional Amblyopia. Amblyopia ex anopsia

Interventions

Intervention 1: Control group: Sham therapy using the Cambridge Vision Stimulator (CAM) device.Participants in this group view the CAM device displaying uniform gray plates with no spatial patterns. E

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: Age between 4 and 8 years Diagnosis of unilateral functional amblyopia Corrected distance visual acuity (CDVA) worse than 0.1 logMAR in the amblyopic eye Presence of at least one amblyogenic factor including anisometropia, strabismus, or both No previous amblyopia treatment except refractive error correction Full-time use of appropriate optical correction for at least 4 months prior to enrollment Cooperation of the child and parents for examinations and follow-up visits Written informed consent obtained from parents or legal guardians

Exclusion criteria

Exclusion criteria: Presence of organic amblyopia. History of previous amblyopia treatment other than refractive correction. History of strabismus surgery. Presence of systemic diseases affecting ocular anatomy or visual function. Premature birth. Presence of ocular pathology other than amblyopia.

Design outcomes

Primary

MeasureTime frame
Change in corrected distance visual acuity (CDVA) of the amblyopic eye, measured using the ETDRS logMAR chart at baseline and at 1, 2, and 4 months after the intervention. Timepoint: The primary outcome will be measured at baseline (before the intervention) and at 1, 2, and 4 months after initiation of the intervention. Method of measurement: Corrected distance visual acuity is measured using the Early Treatment Diabetic Retinopathy Study distance visual acuity chart, and results are recorded on the logarithm of the minimum angle of resolution scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hesam Hashemian

Tehran University of Medical Sciences

h-hashemian@tums.ac.ir+98 21 7753 3939

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026