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A study of Occlusion therapy versus orthoptek magnocellular stimulator therapy for amblyopia

A Randomised Controlled trial on Orthoptek Magnocellular Stimulator versus Occlusion for Amblyopia for the age group of 6 to 19 years, 20 to 40 years and 40 years or more age group

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071150
Enrollment
360
Registered
2024-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: H530- Amblyopia ex anopsia

Interventions

Intervention1: Orthoptek Magnocellular stimulator therapy: The patient will sit at a 1 meter distance from the screen and do exercise of following red and green lights , that flashes at an interval of

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients of refractive and strabismic amblyopia visiting our OPD with clear cornea, strabismus, no lenticular opacities, no retinal or optic nerve pathologies, no mechanical lid cause leading to amblyopia. After proper screening and consent patients of refractive and strabismic amblyopia will be randomized on 4- Block basis with, Mild Amblyopia ââ?¬â?? 30-40%, Moderate Amblyopia 30-40% and Severe Amblyopia ââ?¬â?? 20%. After randomization in the Orthoptek group ââ?¬â?? The patient will sit at a 1 meter distance from the screen and do exercise of following red and green lights , that flashes at an interval of 150msec, from the Amblyopic eye for 20 mins, both eyes open 5-7 mins and 5 mins from the normal eye. After a break / rest of 1 hour patient will asked to count flashing lights for 200-300 times. Patient will do all these activities under supervision of an Optometrist / Resident. So, in 1hour -1 therapy will be over. The Orthoptek therapy will be given on alternate days for the first 2 Weeks ââ?¬â?? 6 Sittings in first 15 days followed by once biweekly for 4 sittings and once monthly therapy for 2 sittings if needed for maintenance. In the conventional Occlusion group ââ?¬â?? Occlusion will be given for 4-6 hours every 5 days per week for 3 months preferably when they are at home and on leave from school, college and office. The non-improving patients at last follow ââ?¬â?? up of 6 months will be managed with other modalities of Amblyopia management.

Exclusion criteria

Exclusion criteria: Patients with any pathological ocular disorders and epilepsy will not be considered

Design outcomes

Primary

MeasureTime frame
To check if any improvement in the best corrected visual acuity, stereopsis and contrast sensitivity.Timepoint: 18months

Secondary

MeasureTime frame
to look for any recurrence and if improvement in the visual acuity, stereopsis and contrast sensitivity following treatment is maintained or not in the subsequent followup.Timepoint: 1 month and 6 months following treatment.

Countries

India

Contacts

Public ContactDr ARVIND KUMAR MORYA

All India Institute of Medical Sciences

bulbul.morya@gmail.com8003996598

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026