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Orthokeratology for Keratoconus
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, December 2008
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00816569
  Purpose

To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients


Condition Intervention
Orthokeratology
Keratoconus
Device: Orthokeratology contact lenses

MedlinePlus related topics: Eye Wear
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Orthokeratology Contact Lenses for Keratoconus

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Uncorrected Visual acuity [ Time Frame: After 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of change in corneal video-topography [ Time Frame: At one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Keratoconus: Experimental
One eye of Keratoconus patient
Device: Orthokeratology contact lenses
Wearing Orthokeratology lens in one eye of a keratoconus patient

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate Keratoconus
  • No apical scars

Exclusion Criteria:

  • Advanced Keratoconus
  • Apical scaring
  • Contact lens intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816569

Contacts
Contact: David Landau, MD 00 972 54 4807077 dvl_eyes@slimail.com
Contact: Boris Savernski, OD 00 972 2 6777111 bopt@bezeqint.net

Locations
Israel
: Hadassah Medical Organization,
Jerusalem,, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: : Hadassah Medical Organization, Jerusalem, Israel ( David Landau MD )
Study ID Numbers: dvleyes-HMO-CTIL
Study First Received: December 31, 2008
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00816569  
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Orthokeratology
Keratoconus

Study placed in the following topic categories:
Corneal Diseases
Eye Diseases
Keratoconus

ClinicalTrials.gov processed this record on January 13, 2009