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

NCT05340699 | Unknown

• 1 other identifier: KY202003
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Changes in Objective cycloplegic refractive

  Changes in objective cycloplegic refractive from baseline between two groups

  baseline, 12 months

• Changes in Axial Length

  Changes in axial length from baseline between two groups

  baseline, 12 months

Secondary Outcomes (4)

• Changes in Objective cycloplegic refractive

  baseline, 6 months，18 months and 24 months

• Changes in Axial length

  baseline, 6 months，18 months and 24 months

• Changes in amplitude of accommodation

  baseline, 6 months，18 months and 24 months

• Changes in near point of convergence

  baseline, 6 months，18 months and 24 months

Study Arms (2)

experimental group

EXPERIMENTAL

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

Device: Defocus Distributed Multi-point lens

control group

ACTIVE COMPARATOR

A group of children wearing single vision lens

Device: Single vision lens

Interventions

Defocus Distributed Multi-point lens DEVICE

Wear DDM lens

experimental group

Single vision lens DEVICE

Wear single vision lens

control group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

Related Publications (1)

• Chen X, Li M, Li J, Wu M, Liu X, Yu C, Guo X, Wang Y, Wang Y, Lu W, Li L, Wang Y. One-year efficacy of myopia control by the defocus distributed multipoint lens: a multicentric randomised controlled trial. Br J Ophthalmol. 2024 Oct 22;108(11):1583-1589. doi: 10.1136/bjo-2023-324243.

  PMID: 38503477 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Xiaoqin Chen, MD

  Tianjin Eye Hospital, Tianjin,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: February 20, 2023
• Study Completion: May 20, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-03

Locations

CN (1)