This trial is active, not recruiting.

Condition keratoconus
Treatments penetrating keratoplasty with intralase, penetrating keratoplasty with vacuum trephine
Phase phase 1
Sponsor Hospital Oftalmologico de Sorocaba
Start date August 2007
End date August 2008
Trial size 60 participants
Trial identifier NCT00566605, 466.07


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
penetrating keratoplasty with intralase
penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty [IEK])
(Active Comparator)
penetrating keratoplasty with vacuum trephine
Group 2 - penetrating keratoplasty with vacuum trephine

Primary Outcomes

Visual acuity
time frame: 1 year

Secondary Outcomes

Pachimetry, Microscopy, Corneal topography
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Visual Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty
Principal investigator Elissandro M Silva, Lindoso
Trial information was received from ClinicalTrials.gov and was last updated in November 2007.
Information provided to ClinicalTrials.gov by Hospital Oftalmologico de Sorocaba.