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Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs

NCT06825585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-13

No results posted yet for this study

Summary

Orthokeratology (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. More recently, it is reported that the children wearing orthok lens of smaller back optical zone diameter (BOZD) demonstrated a smaller axial elongation when compared to children wearing lens with larger BOZD. We aimed to explored the myopia efficacy and visual quality of ortho-k with different BOZD (5.0mm or 6.2mm).

Conditions

  • Myopia
  • Myopia; Refractive Error

Interventions

DEVICE

Orthokeratology with 5.0mm back optical zone diameter

The orthokeratology lenses used in this study were Double Reservoir Lenses (DRL) manufactured by Precilens (Creteil, France). The lenses feature a dual reverse-curve design with a back optic zone diameter (BOZD) of 5.0 mm.

DEVICE

Orthokeratology with a 6.2 mm back optical zone diameter

The orthokeratology lenses used were Euclid lenses manufactured by Euclid Systems (Herndon, VA, USA). These lenses feature a four-zone, five-curve design with a back optic zone diameter (BOZD) of 6.2 mm.

Sponsors & Collaborators

  • Xiaoyan Yang

    lead OTHER

Principal Investigators

  • Tianjin Eye Hospital · Tianjin Eye Hospital Opotometic Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-03-31
Completion
2022-05-31

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 NCT06825585 on ClinicalTrials.gov