Lamellar Transplant With Lyophilized Corneas | NCT00409955

Studies
Lamellar Transplant With Lyophilized Corneas

NCT00409955

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Dec 12, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Keratoconus

Interventions

Lamellar transplant with lyophilized corneas

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Dec 11, 2006

First Submission Date that Met QC Criteria

Dec 11, 2006

First Posted Date

Dec 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2006

Last Update Posted Date

Dec 12, 2006Estimated

Name	Class
University of Sao Paulo	OTHER
Sorocaba Eye Bank	OTHER

Description Module

Brief Summary

- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas

Detailed Description

After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of < 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas.
Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy.
Results are going to be statistically analysed by SPSS program.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Lamellar transplant with lyophilized corneas	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Topography
Orbscan
Pachmetry
Ultrasound Biomicroscopy
Confocal Microscopy
Masked Examiner to evaluate transparency and quality of the transplant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Keratoconus patient
BCVA < 20/60
No systemic diseases
Who signed the inform consent

Exclusion Criteria:

BCVA > 20/60
Presence of deep opacities
Systemic diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberta JM Farias, MD	Federal University of São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Sao Paulo		São Paulo	São Paulo	04023-062	Brazil

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases