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

Not Applicable

Active, not recruiting

• Conditions: Myopia
• Interventions: Device: Defocus Incorporated Multiple Segment (DIMS) Spectacles; Device: Orthokerathology lenses (OKL)

• Registration Number: NCT05134935
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-26
• Study Start: 2022-06-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIMS	Defocus Incorporated Multiple Segment (DIMS) Spectacles	-
OKL	Orthokerathology lenses (OKL)	-

Primary Outcome Measures

Name	Time	Method
Axial length growth of the eye	During 18 months of therapy	Length is measured in mm

Secondary Outcome Measures

Name	Time	Method
Pupil size	During 6 months of therapy	Length is measured in mm
Vision related quality of life using the questionnaire PREP2	Prior to and 9 months after treatment initiation	Range from "strongly disagree" to "strongly agree"
Overall eye length growth, defined as the sum of axial length and choroidal thickness	During 18 months of therapy	Length is measured in mm
Choroidal thickness	During 18 months of therapy	Thickness is measured in um

Trial Locations

Locations (1)

The Ophthalmic department, Vejle Hospital; 🇩🇰 Vejle, Southern Denmark, Denmark