IPS Amblyopia Treatment, phase 3: RCT of a computer program for treating amblyopia

Completed

• Conditions: Eye Diseases: Amblyopia; Eye Diseases; Amblyopia

• Registration Number: ISRCTN98018344
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. No personal history of epilepsy.
2. Willing to attend the Institute of Optometry for the 1-2 pre-treatment appointments, the post treatment assessment, and the follow-up assessment
3. Access to a computer for six approximately weekly sessions for the treatment. Ideally, the treatment will take place on a home computer in a dimly lit room, to simulate the lighting in which IPS is conventionally carried out.
4. Unilateral amblyopia with visual acuity better than 6/36 but worse than 6/9 in the amblyopic eye and 6/6 or better in the non-amblyopic eye.
5. Amblyogenic factor: amblyopic eye is either strabismic or has at least 1D more hypermetropia or 2D more astigmatism than the non-amblyopic eye.
6. No ophthalmoscopically detectable anomalies of fundus or defects of the visual pathway. This will be taken to mean no clinically significant departure from a normal ophthalmoscopic appearance and 30 degree visual fields (static perimetry) within normal limits.
7. Patients must be at least 10 years old and have signed the informed consent form, or have this signed by a parent or guardian if under 16 years old.
8. No history of strabismus or other cause of reduced visual acuity (e.g., cataract) in first two years of life
9. Able and willing to meet the costs of any refractive correction). Anisometropic participants will be encouraged to wear contact lenses as this has been shown to be the best option to minimise aniseikonia (Winn et al., 1988).

The study will continue until there are 30 participants in each group.

Exclusion Criteria

1. Personal history of epilepsy
2. Inability to attend Institute of Optometry for the 1-2 pre-treatment appointments, the post treatment assessment, and the follow-up assessment
3. No access to a computer for six approximately weekly sessions for the treatment
4. Unilateral amblyopia worse than 6/36, or better than 6/9 in the amblyopic eye or worse than 6/6 in the non amblyopic eye.
Refractive amblyopia where the amblyopic eye has less than 1D more hypermetropia or 2D astigmatism than the non amblyopic eye.
Any ophthalmoscopically detectable anomalies of fundus or defects of the visual pathway (30° visual fields by static perimetry outside within normal limits)
5. Patients under 10 years old
6. History of strabismus or other cause of reduced visual acuity in first 2 years of life
7. Unable or unwilling to meet costs of refractive correction

Study & Design

• Study Type: Interventional
• Study Design: Not specified