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CompletedNCT00659308Updated Apr 16, 2008

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

An interventional study of amniotic membrane transplantation and anterior stromal puncture in Bullous Keratopathy, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-16.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bullous Keratopathy

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Keywords

  • pain
  • bullous keratopathy
  • amniotic membrane
  • anterior stromal puncture
03

In context

Corneal Edema

45 studies on the registry are indexed under Corneal Edema; 7 are open to participants now.

This study's enrollment of 38 is close to the median of 42 across 37 interventional studies indexed under Corneal Edema.

Browse Corneal Edema studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • bullous keratopathy

Exclusion criteria

Exclusion Criteria:

  • age under 18 years old
  • asymptomatic bullous keratopathy
  • corneal infection
  • ocular hypertension
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Interventions

  • Procedureamniotic membrane transplantation

    patients are submitted to amniotic membrane transplantation

  • Procedureanterior stromal puncture

    the other group is submitted to anterior stromal puncture

06

Study locations

1 site
  • Federal University of Sao Paulo
    Sao Paulo, 04023-062, Brazil
07

References and documents

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. doi: 10.1001/archopht.117.10.1291. PubMed 10532436 ↗
  • 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. PubMed 11473154 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00659308
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted
Apr 16, 2008
Start date
Jun 2005
Primary completion
Jul 2005
Completion
Jun 2007
Last update
Apr 16, 2008

Study contacts

Fabiana Paris, MD
principal investigator · Federal University of São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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