Back to resultsPhotorefractive Keratectomy and Corneal Cross-linking in Keratoconus
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Ectasia, Corneal Cross-linking
Eligibility Criteria
Inclusion Criteria:
- contact lens intolerance
- corneal thickness > 450 micrometers
- Keratometry < 56 diopters
- Astigmatism < 6 diopters
Exclusion Criteria:
- corneal thickness < 450 micrometers
- Keratometry > 56 diopters
- Astigmatism > 6 diopters
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Refractive surgery
Arm Description
Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking.
Outcomes
Primary Outcome Measures
The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus
The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.
Secondary Outcome Measures
Full Information
NCT ID
NCT02189447
First Posted
July 5, 2014
Last Updated
July 10, 2014
Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
1. Study Identification
Unique Protocol Identification Number
NCT02189447
Brief Title
Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Ectasia, Corneal Cross-linking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Refractive surgery
Arm Type
Experimental
Arm Description
Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking.
Intervention Type
Procedure
Intervention Name(s)
Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
Intervention Description
Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting
Primary Outcome Measure Information:
Title
The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus
Description
The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
contact lens intolerance
corneal thickness > 450 micrometers
Keratometry < 56 diopters
Astigmatism < 6 diopters
Exclusion Criteria:
corneal thickness < 450 micrometers
Keratometry > 56 diopters
Astigmatism > 6 diopters
12. IPD Sharing Statement
Learn more about this trial
Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus
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