NCT00409955

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
Last Updated

December 12, 2006

Status Verified

December 1, 2006

First QC Date

December 11, 2006

Last Update Submit

December 11, 2006

Conditions

Keratoconus

Keywords

Lamellar transplantLyophilizationCorneas storageKeratoconus patientsBest corrected visual acuity < 20/60Signed the consent inform

Outcome Measures

Primary Outcomes (6)

  • Topography

  • Orbscan

  • Pachmetry

  • Ultrasound Biomicroscopy

  • Confocal Microscopy

  • Masked Examiner to evaluate transparency and quality of the transplant

Interventions

Lamellar transplant with lyophilized corneasPROCEDURE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • BCVA \> 20/60
  • Presence of deep opacities
  • Systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Roberta JM Farias, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

December 1, 2005

Study Completion

December 1, 2006

Last Updated

December 12, 2006

Record last verified: 2006-12

Locations

BR(1)