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Clinical Study Of Nearsightedness; TReatment With Orthokeratology Lenses (CONTROL)

NCT03246464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-28

No results posted yet for this study

Summary

Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. High myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and myopic choroidal neovascularization. In myopia the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be controlled the progression of myopia can be controlled. Asian studies have shown reduction in axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic vision during the day, so no glasses or contact lenses are needed. Twin and family studies have shown a high heritability for the development of myopia, and more than 40 genetic loci have been identified indicating that the effect of OKL in Asian children might not be the same in North European children which is why we want to execute a similar study on North European children.

Purpose:

1. Investigate if nightly wear of OKL reduces the progression of childhood myopia (change in axial length) in Danish children when compared to a control group using monofocal glasses.
2. Investigate the safety (Efron score) of OKL.
3. Investigate children's quality of life impact of refractive correction (questionnaire) using OKL compared to glasses.
4. Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus and higher order aberrations).

Method:

A randomized controlled 18 months prospective 1:1 study of a group of Danish children. 60 children will be included; 30 in each group. The participants will undergo several measurements reflecting the anatomy and function of the eye at baseline, 6, 12 and 18 month to evaluate the effect.

Conditions

  • Myopia

Interventions

DEVICE

Orthokeratology lenses

Rigid gas permeable contact lenses

DEVICE

Single-vision spectacles

Regular single vision spectacles

Sponsors & Collaborators

  • Ens Eyes

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2020-04-17
Completion
2020-04-17

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246464 on ClinicalTrials.gov