Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Orthokeratology for Keratoconus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00816569
First received: December 31, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Orthokeratology Contact Lenses for Keratoconus

Resource links provided by NLM:


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
Experimental: Keratoconus
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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816569

Locations
Israel
: Hadassah Medical Organization,
Jerusalem,, Israel, 91120
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 
Study First Received: December 31, 2008
Last Updated: December 31, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Orthokeratology
Keratoconus

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on December 07, 2016