MedDataX Logo

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

NCT ID: NCT00566605

Last Updated: 2007-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Keratoconus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Group Type ACTIVE_COMPARATOR

Penetrating keratoplasty with IntraLase

Intervention Type PROCEDURE

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

Group 2

Group Type ACTIVE_COMPARATOR

Penetrating keratoplasty with vacuum trephine

Intervention Type PROCEDURE

Group 2 - penetrating keratoplasty with vacuum trephine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Penetrating keratoplasty with IntraLase

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

Intervention Type PROCEDURE

Penetrating keratoplasty with vacuum trephine

Group 2 - penetrating keratoplasty with vacuum trephine

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Oftalmologico de Sorocaba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

HOSBOS

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elissandro M Silva, Lindoso

Role: PRINCIPAL_INVESTIGATOR

Hospital Oftalmologico de Sorocaba

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sorocaba Eye Bank - HOSBOS

Sorocaba, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

466.07

Identifier Type: -

Identifier Source: org_study_id