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

Phase 1

• Conditions: Keratoconus
• Interventions: Procedure: Penetrating keratoplasty with IntraLase; Procedure: Penetrating keratoplasty with vacuum trephine

• Registration Number: NCT00566605
• Lead Sponsor: Hospital Oftalmologico de Sorocaba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Status Verified: 2007-11
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-30
• Last Update Submitted: 2007-11-30
• Study First Posted: 2007-12-03
• Last Update Posted: 2007-12-03
• Study Completion: 2008-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Penetrating keratoplasty with IntraLase	-
Group 2	Penetrating keratoplasty with vacuum trephine	-

Primary Outcome Measures

Name	Time	Method
Visual acuity	1 year

Secondary Outcome Measures

Name	Time	Method
Pachimetry, Microscopy, Corneal topography	1 year

Trial Locations

Locations (1)

Sorocaba Eye Bank - HOSBOS; 🇧🇷 Sorocaba, Sao Paulo, Brazil