Status:

UNKNOWN

Myopia-control Efficacy by Peripheral Defocus Lens (PDL)

Lead Sponsor:

Tianjin Eye Hospital

Conditions:

Myopia, Progressive

Eligibility:

All Genders

6-15 years

Phase:

NA

Brief 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 allcoa...

Detailed Description

The proposed study below aims to assess the short-term and long-term effect of customized Bestivue PDL lenses on retinal image quality and myopia control. To these ends, two stages of testing are plan...

Eligibility Criteria

Inclusion

  • The subjects had spherical RE of -1.00 to -6.00 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

  • Strabismus
  • Ocular limitations
  • Systemic abnormalities affecting vision and ocular motility.

Key Trial Info

Start Date :

July 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2022

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT05373693

Start Date

July 1 2019

End Date

September 30 2022

Last Update

May 13 2022

Active Locations (1)

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Tianjin Eye Hospital

Tianjin, China, 300020