Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Hospital Oftalmologico de Sorocaba.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hospital Oftalmologico de Sorocaba
Information provided by:
Hospital Oftalmologico de Sorocaba
ClinicalTrials.gov Identifier:
NCT00566605
First received: November 29, 2007
Last updated: November 30, 2007
Last verified: November 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Keratoconus |
Procedure: Penetrating keratoplasty with IntraLase Procedure: Penetrating keratoplasty with vacuum trephine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty |
Further study details as provided by Hospital Oftalmologico de Sorocaba:
Primary Outcome Measures:
- Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pachimetry, Microscopy, Corneal topography [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 60 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2008 |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566605
Locations
| Brazil | |
| 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 |
More Information
No publications provided
| Responsible Party: | Luciene Barbosa de Sousa, HOSBOS |
| ClinicalTrials.gov Identifier: | NCT00566605 History of Changes |
| Other Study ID Numbers: | 466.07 |
| Study First Received: | November 29, 2007 |
| Last Updated: | November 30, 2007 |
| Health Authority: | Brazil:Anvisa |
Additional relevant MeSH terms:
|
Keratoconus Corneal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013