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Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

NCT05373693 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-05-13

No results posted yet for this study

Summary

The proposed study below aims to assess the effect of customized Bestivue PDL lenses on retinal image quality and myopia control. A total of 160 subjected would be enrolled in and randomized to allcoate into four groups. Visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 D power and single vision lenses would be measured to assess the short term effect of PDL lens. Axial length and cycloplegic objective refractive error would be measured to assess the Myopia-control Efficacy.

Conditions

  • Myopia, Progressive

Interventions

DEVICE

Single vision lens

Wear single vision lens

DEVICE

+2D PDL

Wear Peripheral defocus lense with +2D

DEVICE

+3D PDL

Wear Peripheral defocus lense with +3D

DEVICE

+4D PDL

Wear Peripheral defocus lense with +4D

Sponsors & Collaborators

  • Tianjin Eye Hospital

    lead OTHER

Principal Investigators

  • Lihua Li · Tianjin Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373693 on ClinicalTrials.gov