Status:
COMPLETED
Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation
Lead Sponsor:
Singapore National Eye Centre
Collaborating Sponsors:
International Stem Cell Forum
National Medical Research Council (NMRC), Singapore
Conditions:
Pterygium
Ocular Surface Disease
Eligibility:
All Genders
21-90 years
Phase:
PHASE3
Brief Summary
To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of ocular diseases
Detailed Description
Ex-vivo autologous conjunctiva expansion on human amniotic membrane (HAM), followed by clinical transplantation surgery Preparation of HAM. Human amniotic membrane (HAM) prepared for human use will b...
Eligibility Criteria
Inclusion
- Patients with ocular surface disorders, e.g. primary pterygium, scheduled for elective surgical excision
- 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 21 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 21 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 :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2003
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00346450
Start Date
October 1 2001
End Date
December 1 2003
Last Update
January 13 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Singapore National Eye Centre
Singapore, Singapore, 168751