Health Condition 1: H178- Other corneal scars and opacities
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Intervention2: Ex-vivo cultivated limbal stromal stem cells encapsulated in Alginate: 0.5 million stromal stem cells will be incorporated in 0.05ml of com
Sponsors
Hyderabad Eye Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants who are >=18 and 2. Patients having unilateral superficial corneal pathologies (defined as involving the anterior 200µM of the corneal stroma on ASOCT imaging) 3. Corneal burns, ulcers and scars 4. No prior history of corneal transplantation 5. No ongoing and other active ocular pathology 6. Candidate for stem cell transplant 7. No severe pathological and psychological conditions that might interfere with the patientâ??s participation in the study 8. Able to provide written and audio-visual 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 corneal disease, 2. Corneal scars with limbal dysfunction (clinically defined as absent limbal palisades or conjunctivalization of the cornea) 3. Ocular surface disease including dry eye disease (defined as a Schirmerâ??s test of less than 10mm at 5 minutes), 4. Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation, 5. Children ( 6. Less than 3 months after documented clinical resolution of acute disease 7. Inability/refusal to give written informed consent 8. Undergo any of the anterior segment imaging tests. 9. Patient should have not participated in another clinical study within 30 days of their enrolment on this study. 10. 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. 11. Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential 12. Reproductive age patients not practicing effective and adequate birth control measures 13. Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of ex-vivo cultivated allogeneic limbal stromal stem cells for the treatment of visually significant superficial corneal stromal scarring and other pathologies including any ocular or systemic adverse effects at the various post-operative time points.Timepoint: Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are visual improvement and change in the density and appearance of the corneal scarring and other pathologies after treatment.Timepoint: Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720 | — |
Countries
India
Contacts
Public ContactDr Sayan Basu
LV Prasad Eye Institute
Outcome results
None listed