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

NCT05134935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Myopia

Interventions

DEVICE

Defocus Incorporated Multiple Segment (DIMS) Spectacles

18 months of therapy.

DEVICE

Orthokerathology lenses (OKL)

18 months of therapy.

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Lou-Ann Andersen · Vejle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2025-12-02
Completion
2025-12-02

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134935 on ClinicalTrials.gov