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

This study is ongoing, but not recruiting participants.

First Received: November 29, 2007 Last Updated: November 30, 2007 History of Changes

Sponsor:	Hospital Oftalmologico de Sorocaba
Information provided by:	Hospital Oftalmologico de Sorocaba
ClinicalTrials.gov Identifier:	NCT00566605

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
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
Group 1: Active Comparator	Procedure: Penetrating keratoplasty with IntraLase penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
Group 2: Active Comparator	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, Sao Paulo
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:	HOSBOS ( Luciene Barbosa de Sousa )
Study ID Numbers:	466.07
Study First Received:	November 29, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00566605 History of Changes
Health Authority:	Brazil:Anvisa

Additional relevant MeSH terms:

Corneal Diseases
Eye Diseases
Keratoconus

ClinicalTrials.gov processed this record on November 27, 2009