NCT00566605

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 3, 2007

Status Verified

November 1, 2007

First QC Date

November 29, 2007

Last Update Submit

November 30, 2007

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    1 year

Secondary Outcomes (1)

  • Pachimetry, Microscopy, Corneal topography

    1 year

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Procedure: Penetrating keratoplasty with IntraLase

Group 2

ACTIVE COMPARATOR
Procedure: Penetrating keratoplasty with vacuum trephine

Interventions

Penetrating keratoplasty with IntraLasePROCEDURE

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

Group 1
Penetrating keratoplasty with vacuum trephinePROCEDURE

Group 2 - penetrating keratoplasty with vacuum trephine

Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorocaba Eye Bank - HOSBOS

Sorocaba, São Paulo, Brazil

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Keratoplasty, Penetrating

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Corneal TransplantationTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Elissandro M Silva, Lindoso

    Hospital Oftalmologico de Sorocaba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 3, 2007

Study Start

August 1, 2007

Study Completion

August 1, 2008

Last Updated

December 3, 2007

Record last verified: 2007-11

Locations

BR(1)