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Orthokeratology for Keratoconus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00816569
Recruitment Status : Unknown
Verified December 2008 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2009
Last Update Posted : January 1, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
To investigate a possible benefit of Orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients

Condition or disease Intervention/treatment
Orthokeratology Keratoconus Device: Orthokeratology contact lenses

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Orthokeratology Contact Lenses for Keratoconus
Study Start Date : February 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Keratoconus
One eye of Keratoconus patient
Device: Orthokeratology contact lenses
Wearing Orthokeratology lens in one eye of a keratoconus patient


Outcome Measures

Primary Outcome Measures :
  1. Uncorrected Visual acuity [ Time Frame: After 1 month ]

Secondary Outcome Measures :
  1. Amount of change in corneal video-topography [ Time Frame: At one month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate Keratoconus
  • No apical scars

Exclusion Criteria:

  • Advanced Keratoconus
  • Apical scaring
  • Contact lens intolerance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Not yet recruiting
Jerusalem,, Israel, 91120
Contact: : Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: David Landau, MD         
Sponsors and Collaborators
Hadassah Medical Organization
More Information

Responsible Party: David Landau MD, : Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00816569     History of Changes
Other Study ID Numbers: dvleyes-HMO-CTIL
First Posted: January 1, 2009    Key Record Dates
Last Update Posted: January 1, 2009
Last Verified: December 2008

Keywords provided by Hadassah Medical Organization:
Orthokeratology
Keratoconus

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases