Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Sponsor
Hospital Oftalmologico de Sorocaba (Other)
Overall Status
Unknown status
CT.gov ID
NCT00566605
Collaborator
(none)
60
1
2
12
5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Study Start Date
:
Aug 1, 2007
Anticipated Study Completion Date
:
Aug 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1
|
Procedure: Penetrating keratoplasty with IntraLase
penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
|
| Active Comparator: Group 2
|
Procedure: Penetrating keratoplasty with vacuum trephine
Group 2 - penetrating keratoplasty with vacuum trephine
|
Outcome Measures
Primary Outcome Measures
- Visual acuity [1 year]
Secondary Outcome Measures
- Pachimetry, Microscopy, Corneal topography [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sorocaba Eye Bank - HOSBOS | Sorocaba | Sao Paulo | Brazil |
Sponsors and Collaborators
- Hospital Oftalmologico de Sorocaba
Investigators
- Principal Investigator: Elissandro M Silva, Lindoso, Hospital Oftalmologico de Sorocaba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00566605
Other Study ID Numbers:
- 466.07
First Posted:
Dec 3, 2007
Last Update Posted:
Dec 3, 2007
Last Verified:
Nov 1, 2007
Additional relevant MeSH terms: