Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myopia control lens
Sponsored by
About this trial
This is an interventional prevention trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Age: 5 to 12 years old
- Myopia (spherical equivalent with cycloplegic) ≤ -0.50D
- Astigmatism < 1.50D
- Anisometropia < 1.50D
- Best-corrected visual acuity ≥ 20/20
Exclusion Criteria:
- Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.
- Participants with ocular pathology such as retinal detachment.
- Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.
- Participants with systemic diseases that may affect vision.
Sites / Locations
- Universidad Europea of MadridRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Myopia Control Lens
Arm Description
Outcomes
Primary Outcome Measures
Axial length
Measure of axial length with a biometer
Refraction
Binocular refraction with autorefractometer under cyclopegia
Secondary Outcome Measures
Full Information
NCT ID
NCT05250206
First Posted
February 3, 2022
Last Updated
February 17, 2022
Sponsor
Indizen Optical Technologies, S.L.U.
Collaborators
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT05250206
Brief Title
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
Official Title
Evaluation of Ophthalmic Lenses for Myopia Management
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Anticipated)
Study Completion Date
June 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indizen Optical Technologies, S.L.U.
Collaborators
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myopia Control Lens
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Myopia control lens
Intervention Description
Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.
Primary Outcome Measure Information:
Title
Axial length
Description
Measure of axial length with a biometer
Time Frame
5 minutes
Title
Refraction
Description
Binocular refraction with autorefractometer under cyclopegia
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 5 to 12 years old
Myopia (spherical equivalent with cycloplegic) ≤ -0.50D
Astigmatism < 1.50D
Anisometropia < 1.50D
Best-corrected visual acuity ≥ 20/20
Exclusion Criteria:
Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.
Participants with ocular pathology such as retinal detachment.
Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.
Participants with systemic diseases that may affect vision.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Chamorro, Phd
Phone
+34 (91) 833 37 86
Email
evachamorro@iot.es
Facility Information:
Facility Name
Universidad Europea of Madrid
City
Madrid
ZIP/Postal Code
28670
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
César Villa, Phd
Phone
914111111
Email
villacollarc@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25270192
Citation
Hasebe S, Jun J, Varnas SR. Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014 Sep 30;55(11):7177-88. doi: 10.1167/iovs.12-11462.
Results Reference
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PubMed Identifier
30083910
Citation
Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, Ishiko S, Hieda O, Torii H, Varnas SR, Fujikado T. Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Jpn J Ophthalmol. 2018 Sep;62(5):537-543. doi: 10.1007/s10384-018-0616-3. Epub 2018 Aug 6.
Results Reference
background
PubMed Identifier
22559900
Citation
Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.
Results Reference
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Learn more about this trial
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes
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