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Evaluation of Effectiveness of Correcting Refractive Error With Ready-made Spectacles (RECS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657670
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : October 9, 2009
National Health and Medical Research Council, Australia
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Astigmatism Device: Ready-made spectacles Device: Spectacles Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Ready-made spectacles
Device: Ready-made spectacles
Ready-made spectacles will be dispensed to correct refractive error. Ready-made spectacles are spectacles which are available from an existing inventory. This is different to prescription spectacles which are usually made to order. They have the same spherical power for the right and left eyes and do not include a correction for astigmatism. The limited inventory for this trial includes +1.00 to +4.00 in 0.50 steps, +5.00, +6.00 and +8.00, -1.00 to -6.00 in 0.50 steps, -7.00, -8.00, -9.00 and -10.00. The appropriate spectacles are selected based on the spherical equivalent refractive error. If there is a difference between the two eyes the lower correction is selected.
Other Name: Off-the-shelf spectacles

Active Comparator: 2
Device: Spectacles
Spectacles will be prescribed to correct refractive error. These spectacles will be custom-prescribed based on the sphero-cylindrical refractive correction. The spectacles used in this arm will be custom made for each participant based on their refraction and can be made in a full range of spherical powers and astigmatic corrections for up to 2.00 dioptres of cylinder.
Other Name: Prescription glasses

Primary Outcome Measures :
  1. Wearer retention (% wearing at 1 month), vision (logMAR), visual function (0-100), quality of life (0-100) [ Time Frame: a 1-month period of spectacle wear ]

Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 1-month of spectacle wear ]
  2. Willingness to pay [ Time Frame: 1-month of spectacle wear ]
  3. Recommendations for those who will benefit from ready made spectacles [ Time Frame: 1-month of spectacle wear ]
  4. Quantify the prismatic effects which has an impact of spectacle compliance, need for adaptation and satisfaction with spectacles [ Time Frame: 1-month of spectacle wear ]
  5. Continued spectacle use 6-12 months after dispensing [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   11 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657670

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Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
Shroffs Charity Eye Hospital
New Delhi, India
Sponsors and Collaborators
Johns Hopkins University
National Health and Medical Research Council, Australia
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Principal Investigator: Lisa J Keay, PhD BOptom Johns Hopkins University
Study Director: Guofu Huang, MD Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Director: Monica Gandhi, MD Shroffs Charity Eye Hospital
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lisa Keay, Johns Hopkins University Identifier: NCT00657670    
Other Study ID Numbers: NA00013454
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 2009
Keywords provided by Johns Hopkins University:
refractive error
ready made spectacles
cost effectiveness
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases