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Orthokeratology for Keratoconus

Primary Purpose

Orthokeratology, Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Orthokeratology contact lenses
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthokeratology focused on measuring Orthokeratology, Keratoconus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate Keratoconus
  • No apical scars

Exclusion Criteria:

  • Advanced Keratoconus
  • Apical scaring
  • Contact lens intolerance

Sites / Locations

  • : Hadassah Medical Organization,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Keratoconus

Arm Description

One eye of Keratoconus patient

Outcomes

Primary Outcome Measures

Uncorrected Visual acuity

Secondary Outcome Measures

Amount of change in corneal video-topography

Full Information

First Posted
December 31, 2008
Last Updated
December 31, 2008
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00816569
Brief Title
Orthokeratology for Keratoconus
Official Title
Orthokeratology Contact Lenses for Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthokeratology, Keratoconus
Keywords
Orthokeratology, Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Keratoconus
Arm Type
Experimental
Arm Description
One eye of Keratoconus patient
Intervention Type
Device
Intervention Name(s)
Orthokeratology contact lenses
Intervention Description
Wearing Orthokeratology lens in one eye of a keratoconus patient
Primary Outcome Measure Information:
Title
Uncorrected Visual acuity
Time Frame
After 1 month
Secondary Outcome Measure Information:
Title
Amount of change in corneal video-topography
Time Frame
At one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate Keratoconus No apical scars Exclusion Criteria: Advanced Keratoconus Apical scaring Contact lens intolerance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Landau, MD
Phone
00 972 54 4807077
Email
dvl_eyes@slimail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Savernski, OD
Phone
00 972 2 6777111
Email
bopt@bezeqint.net
Facility Information:
Facility Name
: Hadassah Medical Organization,
City
Jerusalem,
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
: Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
David Landau, MD

12. IPD Sharing Statement

Learn more about this trial

Orthokeratology for Keratoconus

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