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NCT00566605 Clinical Trial

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

Keratoconus Clinical Trial

Official title:
Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00566605
Other study ID # 466.07
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received November 29, 2007
Last updated November 30, 2007
Start date August 2007
Est. completion date August 2008

Study information
Verified date November 2007
Source Hospital Oftalmologico de Sorocaba
Contact n/a
Is FDA regulated No
Health authority Brazil:Anvisa
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date August 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Penetrating keratoplasty with IntraLase
penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
• Penetrating keratoplasty with vacuum trephine
Group 2 - penetrating keratoplasty with vacuum trephine

Locations
Country Name City State
Brazil Sorocaba Eye Bank - HOSBOS Sorocaba Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Hospital Oftalmologico de Sorocaba

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity 1 year Yes
Secondary Pachimetry, Microscopy, Corneal topography 1 year Yes
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