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Effectiveness of Orthokeratology in Myopia Control

NCT03465748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-09-28

Study results available
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Summary

The high prevalence of myopia - especially in Asian countries - is well documented, as are the sight-threatening complications of high or degenerative myopia. Retinal detachment, glaucoma, vitreal degeneration and focal retinal changes may occur secondary to the progressive axial elongation of the eye with age. Specialty rigid lenses have long been shown to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to moderate amounts of myopia. Most of the studies on orthokeratology were conducted on Asian children. To the best of the investigators knowledge, no study has been done on African American (AA) children. The investigators' project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in AA children compared to that in other races.

Conditions

  • Myopia

Interventions

DEVICE

OrthoK

orthok (orthokeratology) is the science of changing the curvature or shape of the cornea to change how light is focused on the retina at the back of one's eye. Specially designed molding retainer contact lenses are placed on the eye at night and are removed upon awakening.

Sponsors & Collaborators

  • Wesley Research Institute

    collaborator OTHER

  • Illinois College of Optometry

    lead OTHER

Principal Investigators

  • Yi Pang, OD · Illinois College of Optometry

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2021-01-31
Completion
2021-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03465748 on ClinicalTrials.gov