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

Primary Purpose

Bullous Keratopathy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
amniotic membrane transplantation
anterior stromal puncture
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Keratopathy focused on measuring pain, bullous keratopathy, amniotic membrane, anterior stromal puncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • bullous keratopathy

Exclusion Criteria:

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

Sites / Locations

  • Federal University of Sao Paulo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 14, 2008
Last Updated
April 14, 2008
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00659308
Brief Title
Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy
Official Title
Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Keratopathy
Keywords
pain, bullous keratopathy, amniotic membrane, anterior stromal puncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
amniotic membrane transplantation
Intervention Description
patients are submitted to amniotic membrane transplantation
Intervention Type
Procedure
Intervention Name(s)
anterior stromal puncture
Intervention Description
the other group is submitted to anterior stromal puncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bullous keratopathy Exclusion Criteria: age under 18 years old asymptomatic bullous keratopathy corneal infection ocular hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabiana Paris, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
10532436
Citation
Pires RT, Tseng SC, Prabhasawat P, Puangsricharern V, Maskin SL, Kim JC, Tan DT. Amniotic membrane transplantation for symptomatic bullous keratopathy. Arch Ophthalmol. 1999 Oct;117(10):1291-7. doi: 10.1001/archopht.117.10.1291.
Results Reference
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PubMed Identifier
11473154
Citation
Gomes JA, Haraguchi DK, Zambrano DU, Izquierdo Junior L, Cunha MC, de Freitas D. Anterior stromal puncture in the treatment of bullous keratopathy: six-month follow-up. Cornea. 2001 Aug;20(6):570-2. doi: 10.1097/00003226-200108000-00003.
Results Reference
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Learn more about this trial

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

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