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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00566605
Enrollment
60
Registered
2007-12-03
Start date
2007-08-31
Completion date
2008-08-31
Last updated
2007-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

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.

Interventions

PROCEDUREPenetrating keratoplasty with IntraLase

penetrating keratoplasty with femtosecond laser shaped incisions- IntraLase TM (IntraLase Enabled Keratoplasty \[IEK\])

PROCEDUREPenetrating keratoplasty with vacuum trephine

Group 2 - penetrating keratoplasty with vacuum trephine

Sponsors

Hospital Oftalmologico de Sorocaba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients older than 18 years old, with keratoconus and corneal transplant indication

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
Visual acuity1 year

Secondary

MeasureTime frame
Pachimetry, Microscopy, Corneal topography1 year

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026