Clinical trial NCT00657670: Evaluation of Effectiveness of Correcting Refractive Error With Ready-made Spectacles
Official title: Evaluation of the Feasibility of Correcting Refractive Error From a Limited Inventory of Ready-made Spectacles: Wearer Retention, Vision Function, Quality of Life and Cost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Astigmatism
Keywords: refractive error
spectacles
ready made spectacles
vision
cost effectiveness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2008-04-14
Enrollment: 800
Sex: ALL
Minimum age (years): 11
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Wearer retention (% wearing at 1 month), vision (logMAR), visual function (0-100), quality of life (0-100)
timeFrame: a 1-month period of spectacle wear
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 1-month of spectacle wear
measure: Willingness to pay
timeFrame: 1-month of spectacle wear
measure: Recommendations for those who will benefit from ready made spectacles
timeFrame: 1-month of spectacle wear
measure: Quantify the prismatic effects which has an impact of spectacle compliance, need for adaptation and satisfaction with spectacles
timeFrame: 1-month of spectacle wear
measure: Continued spectacle use 6-12 months after dispensing
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: New Delhi
country: India
facility: Shroffs Charity Eye Hospital
Study officials:
affiliation: Johns Hopkins University
name: Lisa J Keay, PhD BOptom
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Guofu Huang, MD
role: STUDY_DIRECTOR
affiliation: Shroffs Charity Eye Hospital
name: Monica Gandhi, MD
role: STUDY_DIRECTOR
References:
citation: Zeng Y, Keay L, He M, Mai J, Munoz B, Brady C, Friedman DS. A randomized, clinical trial evaluating ready-made and custom spectacles delivered via a school-based screening program in China. Ophthalmology. 2009 Oct;116(10):1839-45. doi: 10.1016/j.ophtha.2009.04.004. Epub 2009 Jul 9.
citation: Angell B, Ali F, Gandhi M, Mathur U, Friedman DS, Jan S, Keay L. Ready-made and custom-made eyeglasses in India: a cost-effectiveness analysis of a randomised controlled trial. BMJ Open Ophthalmol. 2018 Feb 9;3(1):e000123. doi: 10.1136/bmjophth-2017-000123. eCollection 2018.