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
Sponsor:
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
  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

Resource links provided by NLM:


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 April 17, 2014