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Status unknownNCT05340699Updated Dec 7, 2022

Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control

An interventional study of Defocus Distributed Multi-point lens and Single vision lens in Myopia, sponsored by Tianjin Eye Hospital. Status unknown at 1 site in China. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
6 Years to 13 Years
Sex
All
01

Study summary

Evaluate the safety and effectiveness of experimental group by comparing with the control group

Read the detailed description

Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 168 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Tianjin Eye Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 6-13,with written consent of his/her guardian,regardless of gender;
  • Objective cycloplegic spherical equivalent refractive between -1.00D and 5.00D,and best corrected vision acuity of right and left eyes are better than or equal to 1.0;
  • Astigmatism less than or equal to -1.50D;
  • Voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  • Those with a history of ocular trauma or intraocular surgery;
  • Clinical significant slit-lamp findings;
  • Abnormal IOP(\<10 mmHg , >21 mmHg or difference between two eyes >5mmHg);
  • Patient with other eye diseases,such as uveitis and other inflammation,glaucoma,cataract,fundus disease,eye tumors,eye trauma,strabismus and any lesions that affect vision function;
  • Patient with systemic diseases causing immunosuppression,such as acute or chronic sinusitis,diabetes,Down syndrome,rheumatoid arthritis,psychosis and other conditions that the investigator considers inappropriate for wearing glasses;
  • Those who have participated in other drug clinical trials within 3 months;
  • Only one eye meets the inclusion criteria;
  • Those who cannot have regular eye examinations;
  • Those who have been involved in any myopia control clinical trials,previously used or are using RGP,contact lens and glasses or atropine drugs to control myopia in the past year;
  • The candidates determined by the investigator are not eligible.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    experimental group

    A group of children wearing Xingyouxue Defocus Distributed Multi-point lens

    Device: Defocus Distributed Multi-point lens

  • Active comparator
    control group

    A group of children wearing single vision lens

    Device: Single vision lens

Interventions

  • DeviceDefocus Distributed Multi-point lens

    Wear DDM lens

  • DeviceSingle vision lens

    Wear single vision lens

06

What researchers measure

Primary outcomes

  1. Changes in Objective cycloplegic refractive

    Changes in objective cycloplegic refractive from baseline between two groups

    Time frame: baseline, 12 months

  2. Changes in Axial Length

    Changes in axial length from baseline between two groups

    Time frame: baseline, 12 months

Secondary outcomes

  1. Changes in Objective cycloplegic refractive

    Changes in objective cycloplegic refractive from baseline between two groups

    Time frame: baseline, 6 months，18 months and 24 months

  2. Changes in Axial length

    Changes in axial length from baseline between two groups

    Time frame: baseline, 6 months，18 months and 24 months

  3. Changes in amplitude of accommodation

    Changes in amplitude of accommodation between two groups evey 6 months

    Time frame: baseline, 6 months，18 months and 24 months

  4. Changes in near point of convergence

    Changes in near point of convergence between two groups evey 6 months

    Time frame: baseline, 6 months，18 months and 24 months

07

Study locations

1 site
  • Tianjin Eye Hospital
    Tianjin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05340699
Lead sponsor
Tianjin Eye Hospital
Responsible party
Sponsor
First posted
Apr 22, 2022
Start date
May 1, 2022
Primary completion
Feb 20, 2023 (estimated)
Completion
May 20, 2023 (estimated)
Last update
Dec 7, 2022

Study contacts

Xiaoqin Chen, MD
principal investigator · Tianjin Eye Hospital, Tianjin,China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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