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

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.

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Orthokerathology lenses (OKL); Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Southern Denmark
    • Vejle, Southern Denmark, Denmark, 7100
      • The Ophthalmic department, Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OKL	Device: Orthokerathology lenses (OKL); 18 months of therapy.; Other Names: Night lenses
Experimental: DIMS	Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles; 18 months of therapy.; Other Names: Defocus (DIMS) Spectacles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length growth of the eye	Length in mm is measured 18 months after therapy	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall eye length growth, defined as the sum of axial length and choroidal thickness	Length in mm is measured 18 months after therapy	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Thickness is measured in um	During 18 months of therapy
Vision related quality of life using the questionnaire PREP2	Range from "strongly disagree" to "strongly agree"	Prior to and 9 months after treatment initiation
Pupil size	Length in mm is measured 6 months after therapy	6 months

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Principal Investigator: Lou-Ann Andersen, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): December 2, 2025
• Study Completion (Actual): December 2, 2025

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Equipment and Supplies; Optical Devices; Lenses; Eyeglasses
• Other Study ID Numbers: NISDO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No