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The Berkeley Orthokeratology Study

NCT00000123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2009-09-17

No results posted yet for this study

Summary

To evaluate the relative efficacy of orthokeratology, primarily by assessment of changes in central corneal thickness, astigmatism, visual acuity, endothelial cell density, and corneal curvature.

To evaluate the relative safety of orthokeratology, primarily by assessment of changes in central corneal thickness, astigmatism, visual acuity, endothelial cell density, induced corneal edema, and epithelial staining.

To assess the duration of any orthokeratology treatment effect.

To study the mechanisms by which refractive error and visual acuity changes occur, in particular the contribution that comes from changes in corneal curvature and shape.

To determine whether there were any predisposing ocular factors that could be used to predict which subjects will experience changes or complications.

Conditions

  • Astigmatism
  • Myopia

Interventions

DEVICE

Polymethyl Methacrylate-Silicone Contact Lenses

DEVICE

Polymethyl Methacrylate Contact Lenses

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1978-01-31
Completion
1979-02-28

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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 NCT00000123 on ClinicalTrials.gov