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Clinical Study Of Nearsightedness, TReatment With Orthokeratology Lenses 2 (CONTROL2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774992
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2018
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Ens Eyes
Information provided by (Responsible Party):
Vejle Hospital

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. 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.

Condition or disease Intervention/treatment Phase
Myopia Device: Orthokeratology lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Of Nearsightedness, TReatment With Orthokeratology Lenses 2
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Orthokeratology
Subjects randomized to OKL in the CONTROL-study
Device: Orthokeratology lenses
Custom fit, form stable contact lenses

Experimental: Cross over
Subjects randomized to SVS in the CONTROL-study
Device: Orthokeratology lenses
Custom fit, form stable contact lenses




Primary Outcome Measures :
  1. Axial length [ Time Frame: 18 months ]
    Change in axial length (mm)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects enrolled in the CONTROL-study

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774992


Locations
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Denmark
Vejle Hospital
Vejle, Jylland, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
Ens Eyes
Investigators
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Principal Investigator: Flemming Møller, Dr. med Vejle Hospital and University of Southern Denmark
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT03774992    
Other Study ID Numbers: CONTROL2
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vejle Hospital:
Orthokeratology lenses
Myopia
Children
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases