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OpenTrials
Completed

NCT Number: NCT00409955

Lamellar Transplant With Lyophilized Corneas

- 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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of Sao Paulo

São Paulo, 04023-062, Brazil

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamellar transplant with lyophilized corneas

Procedure

Primary outcomes

  1. Topography

  2. Orbscan

  3. Pachmetry

  4. Ultrasound Biomicroscopy

  5. Confocal Microscopy

  6. Masked Examiner to evaluate transparency and quality of the transplant

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Sorocaba Eye Bank
  • University of Sao Paulo

Registry information

Official study title

Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

Important dates

Study start
2005
Study completion
2006
First posted
Dec 12, 2006
Registry last updated
Dec 12, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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