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

Bullous Keratopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659308
• Other study ID #: cep0728/02
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: April 14, 2008
• Start date: June 2005
• Est. completion date: June 2007

Study information

• Verified date: January 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• bullous keratopathy

Exclusion Criteria:

• age under 18 years old

• asymptomatic bullous keratopathy

• corneal infection

• ocular hypertension

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bullous Keratopathy

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation