Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	Federal University of São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00659308

Purpose

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	Intervention
Bullous Keratopathy	Procedure: amniotic membrane transplantation Procedure: anterior stromal puncture

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title:	Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy

Further study details as provided by Federal University of São Paulo:

Enrollment:	38
Study Start Date:	June 2005
Study Completion Date:	June 2007
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Intervention Details:

patients are submitted to amniotic membrane transplantation

the other group is submitted to anterior stromal puncture

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

bullous keratopathy

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659308

Locations


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


Principal Investigator:	Fabiana Paris, MD	Federal University of Sao Paulo

More Information

Publications:

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.

Gomes JA, Haraguchi DK, Zambrano DU, Izquierdo Júnior 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.

Responsible Party:	Federal University of Sao Paulo ( Fabiana Paris )
Study ID Numbers:	cep0728/02
First Received:	April 14, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00659308
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

pain

bullous keratopathy

amniotic membrane

anterior stromal puncture

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on October 17, 2008