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Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Hospital Oftalmologico de Sorocaba.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566605
First Posted: December 3, 2007
Last Update Posted: December 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Oftalmologico de Sorocaba
  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 (Participant)
Primary Purpose: Treatment
Official Title: Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty

Resource links provided by NLM:


Further study details as provided by Hospital Oftalmologico de Sorocaba:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Pachimetry, Microscopy, Corneal topography [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Luciene Barbosa de Sousa, HOSBOS
ClinicalTrials.gov Identifier: NCT00566605     History of Changes
Other Study ID Numbers: 466.07
First Submitted: November 29, 2007
First Posted: December 3, 2007
Last Update Posted: December 4, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases