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Spectacle wearing among children given ready-made spectacles or prescription spectacles, and cost savings to programmes

Spectacle wearing among children in India given ready-made spectacles or prescription spectacles, and cost savings to programmes: a randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14715120
Enrollment
520
Registered
2015-02-04
Start date
2015-01-05
Completion date
Unknown
Last updated
2023-03-20

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

Conditions

Spectacle wearing in children with uncorrected refractive errors Eye Diseases Refractive errors

Interventions

Children will be randomly allocated to one of two arms: 1. Intervention: ready-made spectacles with the same prescription in each eye 2. Comparator: prescription specta
each eye can have a different prescription, including astigmatic correction. Although ready-made spectacles are available for bulk purchase, in this study all spectacles will be made

Sponsors

London School of Hygiene and Tropical Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 11–15 years 2. Visual acuity (i.e., with spectacles if usually worn) of less than 6/9 in one or both eyes 3. Visual acuity with full correction improves by two or more lines in the better seeing eye 4. Spherical equivalent (i.e., the sum of the myopic or hypermetropic prescription in dioptres (D) plus half the astigmatic cylindrical prescription) corrects the visual acuity to equal to or not more than one line less than best corrected visual acuity with a full prescription in the better eye 5. Difference between the spherical equivalents of the right and left eyes is not >1 D 6. Inter-pupillary distance matches that of ready-made spectacle frames 7. Spectacle frame is of acceptable size and fit

Exclusion criteria

Exclusion criteria: 1. Other causes of visual loss 2. Visual acuity does not improve adequately with a spherical lens 3. >1 D of anisometropia These children will be dispensed prescription spectacles, but will not be recruited to the trial.

Design outcomes

Primary

MeasureTime frame
Proportion of children in each arm of the trial who are wearing their spectacles at unannounced visits 3–4 months after refraction: 1. Children wearing spectacles at the time of the unannounced visit 2. Children not wearing spectacles at the time of the visit, but have them at school 3. Children not wearing spectacles at the time of the visit, but say they are at home 4. Children say they no longer have the spectacles because they are broken or lost Categories 1 or 2 will be defined as spectacle wearing, and categories 3 or 4 as non-spectacle wearing (Wedner, 2008).

Secondary

MeasureTime frame
1. Cost savings to the programme of dispensing ready-made spectacles: this analysis will only be undertaken should the trial demonstrate non-inferiority 2. Reasons for not wearing spectacles, assessed at 8 weeks with a simple questionnaire

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026