Status:

UNKNOWN

Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Lead Sponsor:

Tianjin Eye Hospital

Conditions:

Myopia

Eligibility:

All Genders

6-13 years

Phase:

NA

Brief Summary

Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Detailed Description

Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circu...

Eligibility Criteria

Inclusion

  • 6-13 years old;
  • SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less;
  • Monocular best corrected visual acuity (VA) of 1.0 or better;
  • Acceptance of random group allocation and the masked study design
  • Voluntarily participate in the clinical trial and sign the informed consent;

Exclusion

  • Strabismus.
  • Ocular and systemic abnormalities.
  • Prior experience of myopia control.
  • Only one eye meets the inclusion criteria.

Key Trial Info

Start Date :

May 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT05288335

Start Date

May 1 2022

End Date

December 31 2024

Last Update

December 28 2022

Active Locations (1)

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Tianjin Eye Hospital

Tianjin, China, 300020