Orthokeratology for Keratoconus

Keratoconus Clinical Trial

Official title:

Orthokeratology Contact Lenses for Keratoconus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00816569
• Other study ID #: dvleyes-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 31, 2008
• Last updated: December 31, 2008
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: December 2008
• Source: Hadassah Medical Organization
• Contact: David Landau, MD
• Phone: 00 972 54 4807077
• Email: dvl_eyes[@]slimail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Moderate Keratoconus

• No apical scars

Exclusion Criteria:

• Advanced Keratoconus

• Apical scaring

• Contact lens intolerance

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus
• Orthokeratology

Intervention

Device:
• Orthokeratology contact lenses
Wearing Orthokeratology lens in one eye of a keratoconus patient

Locations

Country	Name	City	State
Israel	: Hadassah Medical Organization,	Jerusalem,

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected Visual acuity		After 1 month	No
Secondary	Amount of change in corneal video-topography		At one month	No