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Completed

NCT Number: NCT05134935

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

The goal of this non-inferiority randomized clinical trial is to compare the myopia control efficacy of Ortho-K lenses (OKL) and Defocus (DIMS) spectacles in myopic children aged 6-12 years. The main question it aims to answer is:

- Is the DIMS spectacle lens not worse than the OKL after 18 months of therapy?

The participants are randomly assigned to either OKL or DIMS spectacles and followed during 18 months of therapy.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ophthalmic department, Vejle Hospital

Vejle, Southern Denmark, 7100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myopic children aged 6 to 12 years: Myopia of the 6 to 8-year-olds (inclusive): -1.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).

Myopia of the 9 to 12-year-olds (inclusive): -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes).

  • Anisometropia ≤ 1.50 D cycloplegic spherical equivalent refractive error.
  • Best corrected visual acuity at age 6 to 12 years (inclusive): 0.8 Snellen (equivalent to ≥ 3/5 letter on the 0.8 line = 78 ETDRS letters)

Exclusion criteria

  • Manifest or intermittent squint.
  • Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic 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 anxiety towards contact lenses).
  • Previous myopia control treatment.

Treatment and study plan

Defocus Incorporated Multiple Segment (DIMS) Spectacles

Device

18 months of therapy.

Other names: Defocus (DIMS) Spectacles

Orthokerathology lenses (OKL)

Device

18 months of therapy.

Other names: Night lenses

Primary outcomes

  1. Axial length growth of the eye

    Time frame: 18 months

    Length in mm is measured 18 months after therapy

Secondary outcomes

  1. Overall eye length growth, defined as the sum of axial length and choroidal thickness

    Time frame: 18 months

    Length in mm is measured 18 months after therapy

Other outcomes

  1. Choroidal thickness

    Time frame: During 18 months of therapy

    Thickness is measured in um

  2. Pupil size

    Time frame: 6 months

    Length in mm is measured 6 months after therapy

  3. Vision related quality of life using the questionnaire PREP2

    Time frame: Prior to and 9 months after treatment initiation

    Range from "strongly disagree" to "strongly agree"

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

Defocus Incorporated Multiple Segment (DIMS) Spectacle Lenses Versus Orthokeratology Lenses (OKL) for Slowing Myopia Progression In Children Aged 6-12 Years. A Non-inferiority Randomized Clinical Trial. The NISDO Study.

Acronym: NISDO

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2021
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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