Evaluation of Effectiveness of Correcting Refractive Error With Ready-made Spectacles (RECS)
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Details and patient eligibility
About
This research project will compare two methods of correcting refractive error (long or short-sightedness) with spectacle lenses. The primary outcome is the proportion of the population requiring spectacle correction who's needs are met through each scheme. Secondary outcomes are the cost effectiveness of these schemes and development of guidelines for identification of those amongst the population suitable for 'ready-made' spectacles.
There are two sites involved in this research. Those with uncorrected refractive error will be identified by their distance vision. Those who have impaired vision (at least 20/40) which improves with spectacles will be invited to participate in this research. Participants will be randomly allocated to one of two groups. The first group will receive spectacles with full correction in both eyes and the second group will receive spectacles from a limited inventory. The two schemes will be compared by how many people continue to use the spectacles, vision with the new spectacles, change in the level of visual functioning and quality of life after wearing new spectacles for one month. At the one month visit, if the spectacles provided are not useful, one new pair of custom spectacles will be dispensed.
Full description
In India, participants will be recruited from those attending Shroff's Charity Eye Hospital for refractive eye care. These individuals are screened for eye disease and visual acuity is measured as part of routine care. All with distance vision worse than 20/40 will have pinhole acuity taken to estimate benefit of refractive correction. Those who have refracted distance visual acuity better than 20/40 in the better eye and minimum spherical refractive error of ±1 dioptre will be eligible for the study. The clinical testing can be conducted on the same day and include habitual distance vision, refraction and refracted visual acuity.
In China, participants will be recruited from those identified by a School Screening Program in place in GuangZhou (Childsight). In this program, teachers measure visual acuity. Those who have 20/40 or worse distance vision will be invited to a parent information night. At this time, information will be provided about the study and those interested in participating will sign a record of informed assent with parental permission. The clinical testing will be conducted at a later visit by an optometrist attending the school. Study questionnaires will be administered and clinical testing of vision including habitual distance vision, refraction and refracted visual acuity.
The duration of the study will be up to 2 months and will require a total of three visits. After the initial visit, the dispensing visit will be arranged based on time to supply spectacles and the final visit planned for 1 month after receipt of spectacles.
This study will be masked. The persons interviewing the patients about quality of life and those testing vision on both visits will not know the intervention status of the subjects.
Enrollment
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Volunteers
Inclusion criteria
- Presenting visual acuity of 20/40 or worse in the better eye, who have improvement to 20/40 or better following refraction
- A minimum of 1 dioptre of spherical refractive error must be present
- Aged 18-45 years of age at Shroffs Charity Eye Hospital
- Junior High School Students approximate age 11-16 years of age at Zhongshan Ophthalmic Center
Exclusion criteria
- Those who do not correct to within 20/40 with spectacle correction.
Trial design
Primary purpose
Allocation
Interventional model
Masking
800 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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