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Clinical Study Of Nearsightedness, TReatment With Orthokeratology Lenses 2

NCT03774992 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-03-04

No results posted yet for this study

Summary

Myopia is a common disease of the eye with increasing prevalence all over the world including Denmark where the prevalence has increased from 12,8% in 2004 among young adults (mean age 19,3 years) till 17,9% in 2017 among school children (mean age 15,4 years). 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.

In the CONTROL-study 60 Danish children aged six to 13 years were randomized 1:1 to either OKL (intervention group) or single vision spectacles (SVS) (control group) and followed for 18 months to compare changes in axial length (AL). In CONTROL2 the intervention group will be followed for another 18 month and the control group will be crossed over to OKL treatment.

The aims of CONTROL2 is to:

1. Investigate changes in axial length after 3 years of OKL wear (DreamliteR, Procornea, Nederlands).
2. Investigate changes in progression rate 18 month before and after OKL wear.
3. Investigate correlations between changes in choroidal thickness and changes in AL.
4. Investigate the safety of OKL treatment (Efron score).
5. Investigate changes in quality of life before and after OKL treatment using Pediatric Refractive Error Profile 2 (PREP2).
6. Investigate correlations between AC/A-ratio, peripheral refraction and higher order aberrations on myopia progression.

Conditions

  • Myopia

Interventions

DEVICE

Orthokeratology lenses

Custom fit, form stable contact lenses

Sponsors & Collaborators

  • Ens Eyes

    collaborator OTHER

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Flemming Møller, Dr. med · Vejle Hospital and University of Southern Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-04
Primary Completion
2021-12-01
Completion
2021-12-01

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 NCT03774992 on ClinicalTrials.gov