Evaluation of Effectiveness of Correcting Refractive Error With Ready-made Spectacles

NCT00657670 | Completed

• 1 other identifier: NA00013454
• Study Type: interventional
• Target: 800
• Locations: 2 countries
• Sites: 2

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.

Conditions

Myopia; Hyperopia; Astigmatism

Keywords

refractive error; spectacles; ready made spectacles; vision; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Wearer retention (% wearing at 1 month), vision (logMAR), visual function (0-100), quality of life (0-100)

  a 1-month period of spectacle wear

Secondary Outcomes (5)

• Cost-effectiveness

  1-month of spectacle wear

• Willingness to pay

  1-month of spectacle wear

• Recommendations for those who will benefit from ready made spectacles

  1-month of spectacle wear

• Quantify the prismatic effects which has an impact of spectacle compliance, need for adaptation and satisfaction with spectacles

  1-month of spectacle wear

• Continued spectacle use 6-12 months after dispensing

  12 months

Study Arms (2)

1

EXPERIMENTAL

Ready-made spectacles

Device: Ready-made spectacles

2

ACTIVE COMPARATOR

Spectacles

Device: Spectacles

Interventions

Ready-made spectacles DEVICE

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.

Also known as: Off-the-shelf spectacles

1

Spectacles DEVICE

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.

Also known as: Prescription glasses

2

Eligibility Criteria

• Age: 11 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Those who do not correct to within 20/40 with spectacle correction.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Health and Medical Research Council, Australia: collaborator

Study Sites (2)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, China

Location

Shroffs Charity Eye Hospital

New Delhi, India

Location

Related Publications (3)

• 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.

  PMID: 19592103 RESULT

• Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

  PMID: 36809645 DERIVED

• 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.

  PMID: 29657979 DERIVED

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism; Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Lisa J Keay, PhD BOptom

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Guofu Huang, MD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

• Monica Gandhi, MD

  Shroffs Charity Eye Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: September 1, 2009
• Last Updated: October 9, 2009

Record last verified: 2009-10

Locations

CN (1); IN (1)