Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659308
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : April 16, 2008
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Federal University of São Paulo

Brief Summary:
The purpose of this study is to determine whether amniotic membrane transplantation is as effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.

Condition or disease Intervention/treatment Phase
Bullous Keratopathy Procedure: amniotic membrane transplantation Procedure: anterior stromal puncture Not Applicable

Detailed Description:
Patients with symptomatic bullous keratopathy were randomized in 2 groups and submitted to amniotic membrane transplantation or anterior stromal puncture. The follow up was made with 1, 3, 6 and 12 months. Evaluation included complete ophthalmologic exam, esthesiometry, pachymetry, impression cytology and evaluation of pain.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy
Study Start Date : June 2005
Actual Primary Completion Date : July 2005
Actual Study Completion Date : June 2007

Intervention Details:
  • Procedure: amniotic membrane transplantation
    patients are submitted to amniotic membrane transplantation
  • Procedure: anterior stromal puncture
    the other group is submitted to anterior stromal puncture



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bullous keratopathy

Exclusion Criteria:

  • age under 18 years old
  • asymptomatic bullous keratopathy
  • corneal infection
  • ocular hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659308


Locations
Layout table for location information
Brazil
Federal University of Sao Paulo
Sao Paulo, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Layout table for investigator information
Principal Investigator: Fabiana Paris, MD Federal University of Sao Paulo

Publications:
Layout table for additonal information
Responsible Party: Fabiana Paris, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00659308     History of Changes
Other Study ID Numbers: cep0728/02
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: January 2008
Keywords provided by Federal University of São Paulo:
pain
bullous keratopathy
amniotic membrane
anterior stromal puncture
Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Edema
Corneal Diseases
Eye Diseases