Status:
UNKNOWN
Transplant of Epithelium Conjunctival Human Autologous Cultivated ex Vivo in Amniotic Membrane for the Treatment of Symblepharon
Lead Sponsor:
Federal University of São Paulo
Conditions:
Symblepharon
Eligibility:
All Genders
16-90 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety and efficacy of human conjunctival epithelial autologous cultivated ex vivo for reconstruction of the ocular surface in patients with symblepharo...
Detailed Description
10 patients will be included from 16 to 90 years with presence of symblepharon, what have been already subjected to proceedings of reconstruction of the ocular surface without success and to present c...
Eligibility Criteria
Inclusion
- Patients with ocular surface disorders, e.g. symblepharon
- Indications for surgery will be the presence of ocular surface symptoms in the affected eye, loss of visual acuity from visual axis obscuration or irregular astigmatism, or cosmesis.
- Only one eye of a patient will be eligible for study entry.
- Patients who are adult males and females who are aged 16 or older, and are considered mentally sound
- Patients who are willing to undergo long-term follow-up, as outlined in this protocol
- Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee.
Exclusion
- Patients less than 16 years of age
- Patients who are incapable, either by law or of mental state, of giving consent in their own right
- Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
- Patients who are pregnant or breastfeeding
- Patients with a history of drug allergy
- Patients who have received an investigational drug within 28 days preceding surgery
- Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma
- Patients who are documented to be steroid responders
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00799526
Start Date
November 1 2008
End Date
November 1 2010
Last Update
December 1 2008
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