NCT05300321

Brief Summary

To confirm the efficacy of DIMS lenses in controlling myopia progression, we planned a prospective randomized controlled clinical study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
Last Updated

April 25, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

March 18, 2022

Last Update Submit

April 15, 2022

Conditions

Myopia, Progressive

Keywords

myopiaaxial lengthDIMS

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic objective refraction

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

    12months

Secondary Outcomes (1)

  • Axial Length

    12months

Study Arms (2)

Single Vision Lens

EXPERIMENTAL

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

Device: frame lens

Defocus Incorporated Multiple Segments (DIMS) Lens

EXPERIMENTAL

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

Device: frame lens

Interventions

frame lensDEVICE

The subjects were randomized to allocate in Single Vision (SV) lens or Defocus Incorporated Multiple Segments (DIMS) Lens group.

Defocus Incorporated Multiple Segments (DIMS) LensSingle Vision Lens

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia, DegenerativeMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Xiaoqin Chen, MD

    Tianjin Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 29, 2022

Study Start

June 1, 2019

Primary Completion

November 30, 2020

Study Completion

April 1, 2021

Last Updated

April 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)