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DIMS-myopia Progression ADN Axial Length Growth

Primary Purpose

Myopia, Progressive

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
frame lens
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia, Progressive focused on measuring myopia, axial length, DIMS

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D
  • Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes.

Exclusion Criteria:

  • Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.

Sites / Locations

  • Tianjin Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single Vision Lens

Defocus Incorporated Multiple Segments (DIMS) Lens

Arm Description

The sunbjects were randomized to allocate in single vision lens group.

The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group.

Outcomes

Primary Outcome Measures

Cycloplegic objective refraction
Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).

Secondary Outcome Measures

Axial Length
Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).

Full Information

First Posted
March 18, 2022
Last Updated
April 15, 2022
Sponsor
Tianjin Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05300321
Brief Title
DIMS-myopia Progression ADN Axial Length Growth
Official Title
Efficacy of Defocus Incorporated Multiple Segments (DIMS) Lens Chinese Myopic Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye 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
To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.
Detailed Description
The subjects were randomly assigned into two groups: the control group (SV) and the experimental group (DIMS). The clinical trial assistant took the glasses before examination and returned them after examiners had performed all tests. Examiners were unaware of the spectacle type until the end of the follow-up period. However, the lens type was known by children and parents since the unique appearance of the DIMS lens. The subjects were provided details about the study design and methodology and their rights as subjects at first visit. We conducted visual acuity tests, subjective and objective refraction measurements, AL measurements, heterophoria at distance and near, and accommodation after obtaining written informed consent from them and their parent. We conducted follow-up examinations 6 and 12 months after the first visit. In the follow-up examinations, we measured all the examination as do ate the firt visit. Either the VA with the current spectacles dropped to < 0.8(20/20) or SE of cycloplegic subjective refraction increased ≤-0.50D, the lens power of the spectacles was replaced on the basis of the cycloplegic subjective refraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive
Keywords
myopia, axial length, DIMS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Vision Lens
Arm Type
Experimental
Arm Description
The sunbjects were randomized to allocate in single vision lens group.
Arm Title
Defocus Incorporated Multiple Segments (DIMS) Lens
Arm Type
Experimental
Arm Description
The sunbjects were randomized to allocate in Defocus Incorporated Multiple Segments (DIMS) Lens group.
Intervention Type
Device
Intervention Name(s)
frame lens
Intervention Description
The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.
Primary Outcome Measure Information:
Title
Cycloplegic objective refraction
Description
Cycloplegic objective refraction was measured with an autorefractor (Topcon KR8900, Japan).
Time Frame
12months
Secondary Outcome Measure Information:
Title
Axial Length
Description
Axial length (AL) was measured with an AL-Scan optical biometer (Nidek, Japan).
Time Frame
12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subjects had spherical RE of -1.00 to -6.50 D, astigmatism ≤ 4.00 D, anisometropia ≤ 1.50 D Best corrected visual acuity (BCVA) equal to or better than logMAR 0.0 (20/20) in both eyes. Exclusion Criteria: Candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqin Chen, MD
Organizational Affiliation
Tianjin Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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DIMS-myopia Progression ADN Axial Length Growth

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