Back to resultsDefocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years. (NISDO)
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Defocus Incorporated Multiple Segment (DIMS) Spectacles
Orthokerathology lenses (OKL)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
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
Sites / Locations
- The Ophthalmic department, Vejle HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
OKL
DIMS
Arm Description
Outcomes
Primary Outcome Measures
Axial length growth of the eye
Length is measured in mm
Secondary Outcome Measures
Overall eye length growth, defined as the sum of axial length and choroidal thickness
Length is measured in mm
Pupil size
Length is measured in mm
Choroidal thickness
Thickness is measured in um
Vision related quality of life using the questionnaire PREP2
Range from "strongly disagree" to "strongly agree"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05134935
Brief Title
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OKL
Arm Type
Active Comparator
Arm Title
DIMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Defocus Incorporated Multiple Segment (DIMS) Spectacles
Other Intervention Name(s)
Defocus (DIMS) Spectacles
Intervention Description
18 months of therapy.
Intervention Type
Device
Intervention Name(s)
Orthokerathology lenses (OKL)
Other Intervention Name(s)
Night lenses
Intervention Description
18 months of therapy.
Primary Outcome Measure Information:
Title
Axial length growth of the eye
Description
Length is measured in mm
Time Frame
During 18 months of therapy
Secondary Outcome Measure Information:
Title
Overall eye length growth, defined as the sum of axial length and choroidal thickness
Description
Length is measured in mm
Time Frame
During 18 months of therapy
Title
Pupil size
Description
Length is measured in mm
Time Frame
During 6 months of therapy
Title
Choroidal thickness
Description
Thickness is measured in um
Time Frame
During 18 months of therapy
Title
Vision related quality of life using the questionnaire PREP2
Description
Range from "strongly disagree" to "strongly agree"
Time Frame
Prior to and 9 months after treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lou-Ann Andersen
Phone
+45 79 40 64 50
Email
Lou-Ann.C.Andersen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lou-Ann Andersen
Organizational Affiliation
Vejle Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ophthalmic department, Vejle Hospital
City
Vejle
State/Province
Southern Denmark
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Defocus (DIMS) Spectacles Versus Ortho-K Lenses (OKL) for Slowing Myopia Progression in Danish Children Aged 6-12 Years.
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