Double-masked randomised controlled trial of an amblyopia treatment

Completed

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

• Registration Number: ISRCTN55960730
• Lead Sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Subjects will be aged 10-65 years. Visual acuity between 6/9 and 6/36 in the amblyopic eye and 6/6 or better in the good eye and where the amblyopia is the result of strabismus or anisometropia. Participants will meet the following selection criteria:

1. No personal history of epilepsy.
2. Willing to attend the Institute of Optometry for the three pre-treatment assessments, six treatment sessions, the post treatment assessment, and the follow-up assessment.
3. 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.
4. Amblyogenic factor: amblyopic eye is either strabismic or has at least 1D more hypermetropia or 2D more astigmatism than the non-amblyopic eye.
5. 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 degrees visual fields (static perimetry) within normal limits.
6. 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.
7. No history of strabismus or other cause of reduced visual acuity (e.g., cataract) in first two years of life.
8. Subjects must have had a recent (within the last 1 year) eye examination and must be wearing the appropriate refractive correction. The cost of this appointment and of any refractive correction will have to be met by the participant. 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). Participants must be adapted to any refractive correction, having worn the correction for at least four months (Stewart et al., 2004).

Exclusion Criteria

1. Personal history of epilepsy.
2. Unilateral amblyopia with visual acuity worse than 6/36 or better than 6/9 in the amblyopic eye and 6/9 or worse in the non-amblyopic eye.
3. Amblyogenic factor: cases where amblyopic eye has less than 1D more hypermetropia or less than 2D more astigmatism than the non-amblyopic eye.
4. Ophthalmoscopically detectable anomalies of fundus or defects of the visual pathway.
5. Patients under 10 years old
6. History of strabismus or other cause of reduced visual acuity (eg cataract) in first two years of life

Study & Design

• Study Type: Interventional
• Study Design: Not specified