Pterygium Clinical Trial
Official title:
Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface
Verified date | January 2010 |
Source | Singapore National Eye Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
To evaluate the use of cultivated conjunctival epithelial equivalents for the treatment of ocular diseases
Status | Completed |
Enrollment | 80 |
Est. completion date | December 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Patients with ocular surface disorders, e.g. primary pterygium, scheduled for elective surgical excision 2. 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. 3. Only one eye of a patient will be eligible for study entry. 4. Patients who are adult males and females who are aged 21 or older, and are considered mentally sound 5. Patients who are willing to undergo long-term follow-up, as outlined in this protocol 6. Patients who have signed an informed consent form that has been approved by the SNEC Ethics Committee. Exclusion Criteria: 1. Patients less than 21 years of age 2. Patients who are incapable, either by law or of mental state, of giving consent in their own right 3. Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol 4. Patients who are pregnant or breastfeeding 5. Patients with a history of drug allergy 6. Patients who have received an investigational drug within 28 days preceding surgery 7. Patients with intraocular pressure over 21 mmHg or history of ocular hypertension or glaucoma 8. Patients who are documented to be steroid responders |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore National Eye Centre | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore National Eye Centre | International Stem Cell Forum, National Medical Research Council (NMRC), Singapore, Singapore Eye Research Institute |
Singapore,
Ang LP, Tan DT, Beuerman RW, Lavker RM. Development of a conjunctival epithelial equivalent with improved proliferative properties using a multistep serum-free culture system. Invest Ophthalmol Vis Sci. 2004 Jun;45(6):1789-95. — View Citation
Ang LP, Tan DT, Phan TT, Li J, Beuerman R, Lavker RM. The in vitro and in vivo proliferative capacity of serum-free cultivated human conjunctival epithelial cells. Curr Eye Res. 2004 May;28(5):307-17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epithelialisation | |||
Primary | Graft integrity | |||
Primary | Resolution of inflammation | |||
Primary | Visual acuity | |||
Primary | Complications | |||
Secondary | Degree of scarring |
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