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NCT05134935 | Recruiting | Myopia

Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.
Sponsor:

Vejle Hospital

Brief Summary:

The purpose is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in Danish myopic children aged 6-12 years. It is a clinical randomized non-inferiority trial, where the participants are randomly assigned to either OKL or DIMS spectacles. The participants are followed during 18 months of therapy. The hypotheses: There is no statistically significant difference between the myopia control efficacy between OKL and DIMS spectacles. Larger pupil size is positively correlated to treatment efficacy for both devises. Increasing choroidal thickness during early treatment is positively correlated to treatment efficacy for both devises. There is no difference in vision related quality of life between the two groups.

Condition or disease

Myopia

Intervention/treatment

Defocus Incorporated Multiple Segment (DIMS) Spectacles

Orthokeratology lenses (OK)

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 84 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) Versus Orthokerathology Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years. The Noninferiority NISDO Study.
Actual Study Start Date : June 29, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025
Arm Intervention/treatment

Active Comparator: REASON

Device: Orthokeratology lenses (OK)

Experimental: DIMS

Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles
Ages Eligible for Study: 6 Years to 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Myopic children aged 6 to 12 years. Myopia of the 6 to 8-year-olds: -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism. Myopia of the 9 to 12-year-olds: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism.
  • Anisometropia < 1,5 D cycloplegic spherical equivalent refractive error.
  • Best corrected visual acuity: Age 6 to 8 (inclusive) years: 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters). Age 9 to 12 years: 1.0 Snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 ETDRS letters)
Exclusion Criteria
  • Manifest or latent squint.
  • Contraindications to the use of OKL comprising keratoconus, chronic allergic conjunctivitis and keratoconjunctivitis sicca.
  • Previous eye surgery.
  • Chronic eye disease demanding daily use of eye drops.
  • Non-compliance to eye examinations
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.

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Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.

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Locations

Recruiting

Denmark, Southern Denmark

The Ophthalmic department, Vejle Hospital

Vejle, Southern Denmark, Denmark, 7100