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

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00657670
First received: April 11, 2008
Last updated: October 8, 2009
Last verified: October 2009
  Purpose

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 Intervention
Myopia
Hyperopia
Astigmatism
Device: Ready-made spectacles
Device: Spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: 1-month of spectacle wear ] [ Designated as safety issue: No ]
  • Willingness to pay [ Time Frame: 1-month of spectacle wear ] [ Designated as safety issue: No ]
  • Recommendations for those who will benefit from ready made spectacles [ Time Frame: 1-month of spectacle wear ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Continued spectacle use 6-12 months after dispensing [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Spectacles
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

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

Ages Eligible for Study:   11 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657670

Locations
China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
India
Shroffs Charity Eye Hospital
New Delhi, India
Sponsors and Collaborators
Johns Hopkins University
National Health and Medical Research Council, Australia
Investigators
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
  More Information

Publications:
Responsible Party: Lisa Keay, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00657670     History of Changes
Other Study ID Numbers: NA00013454
Study First Received: April 11, 2008
Last Updated: October 8, 2009
Health Authority: United States: Institutional Review Board
India: Institutional Review Board

Keywords provided by Johns Hopkins University:
refractive error
spectacles
ready made spectacles
vision
cost effectiveness

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on November 27, 2014