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

Myopia Clinical Trial

— NISDO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134935
• Other study ID #: NISDO
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: Vejle Hospital
• Contact: Lou-Ann Andersen
• Phone: +45 79 40 64 50
• Email: Lou-Ann.C.Andersen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Defocus Incorporated Multiple Segment (DIMS) Spectacles
18 months of therapy.
• Orthokerathology lenses (OKL)
18 months of therapy.

Locations

Country	Name	City	State
Denmark	The Ophthalmic department, Vejle Hospital	Vejle	Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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