Health Condition 1: null- Limbal Stem Cell Deficiency
Conditions
Interventions
Intervention1: Poly Lactide-co-Glycolic Acid(PLGA) biodegradable, synthetic carrier membrane / LECPLGA50:50P1: Poly(lactide-co-glycolide) (50/50) non-woven scaffold
discs fabricated from Purasorb PDLG
Sponsors
Wellcome Trust for Affordable Healthcare India R D
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants who are >=18 years of age. 2. Patients having a confirmed diagnosis of total LSCD as confirmed by any one or all of the following: a. In-growth of conjunctival epithelium over the cornea (conjunctivalization), b. 360o absence of limbal Palisades of Vogt, c. A fine stippled appearance on fluorescein staining, d. Persistent or recurrent corneal epithelial defects e. Superficial vascularization, f. Dull and irregular corneal epithelium. 3. Participants having unilateral limbal stem cell deficiency due to chemical injury 4. No prior history of limbal transplantation 5. No ongoing and other active ocular pathology 6. No severe pathological and psychological conditions that might interfere with the patients participation in the study 7. Able to provide written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice.
Exclusion criteria
Exclusion criteria: 1. Bilateral LSCD 2. LSCD due to autoimmune disorders and partial LSCD 3. Having other ongoing ocular pathologies and acute ocular inflammation 4. Previous neoplastic/cancer disease 5. Severe dry eyes confirmed by Schirmerâ??s test 6. Acute systemic infections 7. Prior history of limbal transplantation surgery or multiple surgeries in the limbal region 8. Substance abuse, medical, psychological or social conditions that may, in the opinion of the investigator, interfere with the patientâ??s participation in the study or evaluation of the study results. 9. Any uncontrolled, inter-current illness that in the opinion of the Investigator may interfere with study evaluation. 10. Participants with uncontrolled diabetes will be excluded from the study 11. History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization. 12. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential 13. Reproductive age patients not practicing effective and adequate birth control measures 14. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study. 15. Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Efficacy PLGA biodegradable synthetic membrane when used in corneal transplantTimepoint: Day 1, Day 10, Day 30, Day 60, Day 90, Day 180 and Day 360 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in VisionTimepoint: Day 30, Day 60, Day 90, Day 180 and Day 360 | — |
Countries
India
Contacts
Public ContactDr Charanya Ramachandran
LV Prasad Eye Institute
Outcome results
None listed