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Double-masked randomised controlled trial of an amblyopia treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55960730
Enrollment
64
Registered
2005-09-30
Start date
2001-11-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Eye Diseases: Amblyopia Eye Diseases Amblyopia

Interventions

Patients meeting strict diagnostic criteria for amblyopia are randomly allocated to an experimental and a control group. The control treatment (modified CAM) was developed to give subjects the same de

Sponsors

Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
A table of findings will be drawn up describing the characteristics of the participants in the experimental group (e.g., age of onset, type of amblyopia, age at treatment) and participants will be ranked in this table in terms of their improvement in VA following treatment (based on their own z-score of improvement). The data will be inspected to see if there are any trends whereby particular types or sub-groups of amblyopia improve with IPS.

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026