NCT00659308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
Last Updated

April 16, 2008

Status Verified

January 1, 2008

Enrollment Period

1 month

First QC Date

April 14, 2008

Last Update Submit

April 14, 2008

Conditions

Bullous Keratopathy

Keywords

painbullous keratopathyamniotic membraneanterior stromal puncture

Interventions

amniotic membrane transplantationPROCEDURE

patients are submitted to amniotic membrane transplantation

anterior stromal puncturePROCEDURE

the other group is submitted to anterior stromal puncture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bullous keratopathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (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. doi: 10.1001/archopht.117.10.1291.

    PMID: 10532436BACKGROUND

  • 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.

    PMID: 11473154BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fabiana Paris, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2008

First Posted

April 16, 2008

Study Start

June 1, 2005

Primary Completion

July 1, 2005

Study Completion

June 1, 2007

Last Updated

April 16, 2008

Record last verified: 2008-01

Locations

BR(1)