Clinical Study Of Nearsightedness, TReatment With Orthokeratology Lenses 2

NCT03774992 | Completed DMC

• 1 other identifier: CONTROL2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Myopia

Keywords

Orthokeratology lenses; Myopia; Children

Outcome Measures

Primary Outcomes (1)

• Axial length

  Change in axial length (mm)

  18 months

Study Arms (2)

Orthokeratology

EXPERIMENTAL

Subjects randomized to OKL in the CONTROL-study

Device: Orthokeratology lenses

Cross over

EXPERIMENTAL

Subjects randomized to SVS in the CONTROL-study

Device: Orthokeratology lenses

Interventions

Orthokeratology lenses DEVICE

Custom fit, form stable contact lenses

Cross over; Orthokeratology

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• subjects enrolled in the CONTROL-study

You may not qualify if:

• none

Sponsors & Collaborators

• Vejle Hospital: lead
• Ens Eyes: collaborator

Study Sites (1)

Vejle Hospital

Vejle, Jylland, 7100, Denmark

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Flemming Møller, Dr. med

  Vejle Hospital and University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: January 4, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Locations

DK (1)