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

NCT03246464 | Completed

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

Brief 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. 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. 2.Investigate the safety (Efron score) of OKL.
3. 3.Investigate children's quality of life impact of refractive correction (questionnaire) using OKL compared to glasses.
4. 4.Identify possible predictors for progression of myopia (AC/A ratio, peripheral defocus and higher order aberrations).

Conditions

Myopia

Keywords

Contact lenses; Children; Myopia

Outcome Measures

Primary Outcomes (1)

• Progression of myopia defined as change in axial length 18 months after start of intervention

  Follow up to 18 months

Secondary Outcomes (3)

• Quality of life comparison between myopic children wearing glasses and orthokeratology lenses using the Pediatric Refractive Error Profile 2 Questionnaire

  Follow up to 18 months

• Safety evaluation by Efron scores for orthokeratology lenses

  Follow up to 18 months

• Accommodation and higher-order aberrations

  Follow up to 18 months

Study Arms (2)

Single-vision spectacles

PLACEBO COMPARATOR

Device: Single-vision spectacles

Orthokeratology lenses

ACTIVE COMPARATOR

Device: Orthokeratology lenses

Interventions

Orthokeratology lenses DEVICE

Rigid gas permeable contact lenses

Orthokeratology lenses

Single-vision spectacles DEVICE

Regular single vision spectacles

Single-vision spectacles

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Myopia -0.5 to -4.75 dioptries spherical in one or both eyes.
• Regular astigmatism ≤ -2.5 diopters in one or both eyes.
• Age 6 ≥ 12 years.
• Anisometropia \< 1.5 D spherical equivalent.
• Best corrected visual acuity of 0.1 logMAR or better in both eyes.
• Acceptance of treatment randomization.

You may not qualify if:

• Manifest or latent squint.
• Contraindications to the use of OKL comprising keratoconus, allergic conjunctivitis and keratoconjunctivitis sicca.
• Previous eye surgery.
• Chronic eye disease demanding daily use of eye drops.
• Non-compliance to eye examinations (unstable fixation or intolerance to OKL).
• One or both parents being ethnical Asian, African, Hispanic or Spanish.

Sponsors & Collaborators

• Vejle Hospital: lead
• Ens Eyes: collaborator

Study Sites (1)

Vejle Hospital

Vejle, Jylland, 7100, Denmark

Location

Related Publications (1)

• Cerullo C, Moller F, Ewan R, Norgaard B, Jakobsen TM. Vision-related quality of life in children: Cross-cultural adaptation and test-retest reliability of the Danish version of the paediatric refractive error profile 2. Acta Ophthalmol. 2024 Sep;102(6):e970-e983. doi: 10.1111/aos.16685. Epub 2024 Apr 13.

  PMID: 38613420 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

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

Model Details: Randomized controled clinical interventional trial

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: August 11, 2017
• Study Start: March 1, 2017
• Primary Completion: April 17, 2020
• Study Completion: April 17, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)