Back to resultsOutcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Primary Purpose
Keratoconus
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Penetrating keratoplasty with IntraLase
Penetrating keratoplasty with vacuum trephine
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years old, with keratoconus and corneal transplant indication
Exclusion Criteria:
- Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40
Sites / Locations
- Sorocaba Eye Bank - HOSBOS
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Pachimetry, Microscopy, Corneal topography
Full Information
NCT ID
NCT00566605
First Posted
November 29, 2007
Last Updated
November 30, 2007
Sponsor
Hospital Oftalmologico de Sorocaba
1. Study Identification
Unique Protocol Identification Number
NCT00566605
Brief Title
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Official Title
Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Oftalmologico de Sorocaba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Penetrating keratoplasty with IntraLase
Intervention Description
penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
Intervention Type
Procedure
Intervention Name(s)
Penetrating keratoplasty with vacuum trephine
Intervention Description
Group 2 - penetrating keratoplasty with vacuum trephine
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pachimetry, Microscopy, Corneal topography
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years old, with keratoconus and corneal transplant indication
Exclusion Criteria:
Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elissandro M Silva, Lindoso
Organizational Affiliation
Hospital Oftalmologico de Sorocaba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorocaba Eye Bank - HOSBOS
City
Sorocaba
State/Province
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
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