Bullous KeratopathyNCT00659308
Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy
A study testing amniotic membrane transplantation and anterior stromal puncture in people with Bullous Keratopathy, run by Federal University of São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Keratopathy
- What is being tested?
- amniotic membrane transplantation and anterior stromal puncture
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2005to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bullous keratopathy
Who cannot join
- age under 18 years old
- asymptomatic bullous keratopathy
- corneal infection
- ocular hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy
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.
- Conditions
- Bullous Keratopathy
- Being tested
- amniotic membrane transplantation, anterior stromal puncture
- Keywords
- pain, bullous keratopathy, amniotic membrane, anterior stromal puncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniotic membrane transplantationProcedure or surgery
patients are submitted to amniotic membrane transplantation
anterior stromal punctureProcedure or surgery
the other group is submitted to anterior stromal puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startJun 2005
- Primary completionJul 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bullous KeratopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Fabiana Paris, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659308
- Sponsor's protocol ID
- cep0728/02
- Status last verified
- Jan 2008
- First submitted
- 14 Apr 2008
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
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 10532436Gomes 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy
- ClinicalTrials.gov ID
- NCT00659308
- Acronym / sponsor ID
- cep0728/02
- Conditions
- Bullous Keratopathy
- Keywords
- pain, bullous keratopathy, amniotic membrane, anterior stromal puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2005
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bullous keratopathy
Key exclusion criteria (4 listed)
- age under 18 years old
- asymptomatic bullous keratopathy
- corneal infection
- ocular hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amniotic membrane transplantationpatients are submitted to amniotic membrane transplantation | Procedure or surgery | – |
| anterior stromal puncturethe other group is submitted to anterior stromal puncture | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2008.
- Background: PubMed 10532436Pires 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.
- Background: PubMed 11473154Gomes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabiana Paris, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amniotic membrane transplantation and anterior stromal puncture in people with Bullous Keratopathy, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00659308, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2008.