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Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

Primary Purpose

Myopia, Progressive

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Double Helix Design Defocus Lens Spectacle (RACE)
single-vision spetacle lens
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia, Progressive

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Race: Chinese children and adolescents. Age 6-13 years, gender unrestricted. Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes. Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6). Refractive astigmatism and astigmatism are no more than 1.5D. During the study period, willing to wear glasses provided by the researcher only (>10 hours) and without additional interventions. Willing to be randomly assigned. Able to sign an informed consent form with the accompaniment and understanding of parents or guardians. Exclusion Criteria: Allergic or intolerant to medications used for ciliary muscle paralysis. Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study. Received defocus lenses for nearsightedness treatment in the past. Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.). History of eye surgery (including strabismus correction surgery). Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames. Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.

Sites / Locations

  • Xiangui HeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Double Helix Design Defocus Lens Spectacle (RACE) for 2 years

st year: single-vision spectacle lenses nd year: double helix design defocus lens spectacle (RACE)

Outcomes

Primary Outcome Measures

Spherical Equivalent change
cycloplegic SE change

Secondary Outcome Measures

Axial Length change
Visual Acuity change

Full Information

First Posted
May 30, 2023
Last Updated
May 30, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT05894382
Brief Title
Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control
Official Title
A Randomized Controlled Study on the Effectiveness, Safety and Adaptability of Double Helix Design Defocus Lens Spectacle Frames for Correction of Visual Acuity in Children and Adolescents, and Control of Myopia.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2023 (Anticipated)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center

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
This study uses 1.585 double helix defocus lens PC lenses with a unique optical design that includes a globally coherent visible area and complementary left and right helices that can form clear images. In addition, the helical arrangement and reduced slit area can generate defocusing signals, inhibiting the development of myopia. Therefore, based on previous research, this study plans to evaluate the safety and effectiveness of 1.585 double helix defocus lens PC frame eyeglasses in controlling the progression of myopia in children and adolescents through a randomized controlled clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Double Helix Design Defocus Lens Spectacle (RACE) for 2 years
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
st year: single-vision spectacle lenses nd year: double helix design defocus lens spectacle (RACE)
Intervention Type
Device
Intervention Name(s)
Double Helix Design Defocus Lens Spectacle (RACE)
Intervention Description
Double Helix Design Defocus Lens Spectacle wearing more than 10h/day.
Intervention Type
Device
Intervention Name(s)
single-vision spetacle lens
Intervention Description
single-vision spetacle lens wearing more than 10h/day.
Primary Outcome Measure Information:
Title
Spherical Equivalent change
Description
cycloplegic SE change
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Axial Length change
Time Frame
1 year
Title
Visual Acuity change
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Race: Chinese children and adolescents. Age 6-13 years, gender unrestricted. Cycloplegic refraction SER: -0.75DS~-5.0DS in both eyes. Best corrected visual acuity of both eyes reaches 1.0 (0.00 logMAR 6/6). Refractive astigmatism and astigmatism are no more than 1.5D. During the study period, willing to wear glasses provided by the researcher only (>10 hours) and without additional interventions. Willing to be randomly assigned. Able to sign an informed consent form with the accompaniment and understanding of parents or guardians. Exclusion Criteria: Allergic or intolerant to medications used for ciliary muscle paralysis. Received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within 30 days before the study. Received defocus lenses for nearsightedness treatment in the past. Diagnosed with any eye disease other than nearsightedness, including strabismus (esotropia greater than 8 prism diopters or exotropia greater than 12 prism diopters), corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.). History of eye surgery (including strabismus correction surgery). Eye or systemic diseases that might be associated with nearsightedness or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc. Anatomical or dermatological factors that may interfere with the wearing of spectacle frames. Other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
Facility Information:
Facility Name
Xiangui He
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201103
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linlin Du
Phone
+862153555032
Email
dllcrco@shsyf.com

12. IPD Sharing Statement

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Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

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