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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00659308
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 38
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bullous Keratopathy	Procedure: amniotic membrane transplantation; Procedure: anterior stromal puncture	N/A

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.

Study Design

• Study Type: Interventional
• 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: Jun 1, 2005
• Actual Primary Completion Date: Jul 1, 2005
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• bullous keratopathy

Exclusion Criteria:

• age under 18 years old

• asymptomatic bullous keratopathy

• corneal infection

• ocular hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00659308
• Other Study ID Numbers: cep0728/02
• First Posted: Apr 16, 2008
• Last Update Posted: Apr 16, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: pain; bullous keratopathy; amniotic membrane; anterior stromal puncture
• Additional relevant MeSH terms: Corneal Edema

Study Results

No Results Posted as of Apr 16, 2008