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MyopiaRECSNCT00657670

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

A study testing Ready-made spectacles and Spectacles in people with Myopia and Hyperopia, run by Johns Hopkins University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Myopia, Hyperopia, Astigmatism
What is being tested?
Ready-made spectacles and Spectacles
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
2 sitesin 2 countries
Study dates
Apr 2008to Sep 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

China1 site

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou

Other trials in China

India1 site

  • Shroffs Charity Eye Hospital

    New Delhi

Other trials in India

About this study

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

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.

Read the 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.

Being tested
Ready-made spectacles, Spectacles
Keywords
refractive error, spectacles, ready made spectacles, vision, cost effectiveness
Medical subject headings
Myopia, Hyperopia, Astigmatism, Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ready-made spectaclesDevice

    Also called Off-the-shelf 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.

  • SpectaclesDevice

    Also called Prescription glasses

    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.

Study groups in NCT00657670
Study groupRoleWhat they receive
1ExperimentalReady-made spectacles
Receives: Device: Ready-made spectacles
2Active comparatorSpectacles
Receives: Device: Spectacles

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: a 1-month period of spectacle wear

Secondary outcomes (5)

  1. Cost-effectiveness

    Measured: 1-month of spectacle wear

  2. Willingness to pay

    Measured: 1-month of spectacle wear

  3. Recommendations for those who will benefit from ready made spectacles

    Measured: 1-month of spectacle wear

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

    Measured: 1-month of spectacle wear

  5. Continued spectacle use 6-12 months after dispensing

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionNov 2008
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657670
Sponsor's protocol ID
NA00013454
Acronym
RECS
Status last verified
Oct 2009
First submitted
11 Apr 2008
Last updated
9 Oct 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19592103

  • 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.

    PubMed 36809645

  • 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.

    PubMed 29657979

Questions about this trial

What is this clinical trial studying?

A study testing Ready-made spectacles and Spectacles in people with Myopia and Hyperopia, run by Johns Hopkins University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00657670, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2009.

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