NCT00816569

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 1, 2009

Status Verified

December 1, 2008

Enrollment Period

5 months

First QC Date

December 31, 2008

Last Update Submit

December 31, 2008

Conditions

OrthokeratologyKeratoconus

Keywords

OrthokeratologyKeratoconus

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Visual acuity

    After 1 month

Secondary Outcomes (1)

  • Amount of change in corneal video-topography

    At one month

Study Arms (1)

Keratoconus

EXPERIMENTAL

One eye of Keratoconus patient

Device: Orthokeratology contact lenses

Interventions

Orthokeratology contact lensesDEVICE

Wearing Orthokeratology lens in one eye of a keratoconus patient

Keratoconus

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Moderate Keratoconus
  • No apical scars

You may not qualify if:

  • Advanced Keratoconus
  • Apical scaring
  • Contact lens intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

: Hadassah Medical Organization,

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

David Landau, MD

CONTACT

00 972 54 4807077dvl_eyes@slimail.com

Boris Savernski, OD

CONTACT

00 972 2 6777111bopt@bezeqint.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 1, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

January 1, 2009

Record last verified: 2008-12

Locations

IL(1)