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

Hospital Oftalmologico de Sorocaba

Status and phase: Unknown; Phase 1

Conditions: Keratoconus

Treatments: Procedure: Penetrating keratoplasty with IntraLase; Procedure: Penetrating keratoplasty with vacuum trephine

Study type: Interventional

Funder types: Other

Identifiers

NCT00566605

466.07

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group 1

Active Comparator group

Treatment:

Procedure: Penetrating keratoplasty with IntraLase

Group 2

Active Comparator group

Treatment:

Procedure: Penetrating keratoplasty with vacuum trephine