Patients with keratoconjunctival disease (Stevens-Johnson syndrome, ocular pemphigoid, or severe thermal/chemical injury)
Conditions
Interventions
Corneal reconstruction (improvement of vision and epithelial repair) Conjunctival sac reconstruction (adhesion separation)
Sponsors
Kyoto Prefectural University of Medicine
Foundation for Biomedical Research and Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Being diagnosed with intractable keratoconjunctival disease due to the following diseases: a) Stevens Johnson syndrome, b) ocular pemphigoid, or c) severe thermal/chemical injury). 2) Afflicted with a bilateral disease with no availability of a therapeutic option that utilizes autologous tissue transplantation. 3) Being 15 years of age or older and younger than 86 years of age at the time of obtaining informed consent. 4) Patients undergoing transplantation for the purpose of recovering vision, improving epithelial defects, or improving ocular surface adhesion. In addition, scores and values for each purpose at the time of registration are as follows: Improvement of vision: Patients with decimal visual acuity of less than 0.1. Improvement of epithelial defects: Patients with a total score value for epithelial defects, conjunctival invasion, and vascular invasion of 3 or higher. These are the three ophthalmological findings scores stipulated in the present study. Detachment of ocular surface adhesion: Patients with 50% or greater adhesion either on the upper or lower conjunctival sac. 5) Patients or their representatives (both the patient and their representative if the patient is between 15 and 20 years of age) from whom written informed consent is obtained.
Exclusion criteria
Exclusion criteria: 1) Having an active corneal infection. 2) Having glaucoma with insufficient ocular pressure control. 3) Patients diagnosed as being complicated with, or carriers of, any of the following diseases: HBV, HCV, HIV, HTLV, or syphilis. 4) Diabetic patients with insufficient glucose control. 5) Patients who are hypersensitive to cyclosporine or steroids. 6) Pregnant women, female patients who have expressed their desire to become pregnant during the course of the study, or those who are currently breastfeeding a child. 7) Patients for whom participation in the present study is believed to be inappropriate due to personal complications or other reasons. 8) Patients who have been diagnosed with any of the following intractable keratoconjunctival diseases: severe recurring pterygium, aniridia, cicatricial pemphigoid, and stem cell deficiency due to drug toxicity or due to an unknown cause. 9) Patients complicated with systemic autoimmune diseases. 10) Patients with visual impairment which is strongly suspected to be affected by other causes. 11) Patients who have already undergone the present protocol treatment. 12) Patients who are currently using or are planning to use anti-cancer agents. 13) Patients with a past history (or those complicated with) cardiac diseases, or cerebrovascular disorders. 14) Patients with impaired eyelid closure due to eyelid function disorders if the purpose of treatment is corneal reconstruction (the purpose of recovering vision or repairing the epithelium). 15) Patients for whom it has been determined that it is difficult to collect the oral cavity mucosal tissue which is required for creating the test material for the present study. 16) Patients for whom it has been determined by the principal investigator or other researchers that there will be complicating issues with the patient participating in the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in distance vision (5 meters) from before transplantation to postoperative Week 24. 2)Change in total epithelial abnormality score (out of the total ophthalmological findings A score, the total score for epithelial defects, conjunctival invasion, and vascular invasion) from before transplantation to postoperative Week 24. 3)Change in conjunctival sac adhesion score (total of scores for upper and lower) within ophthalmological findings A from before transplantation to postoperative Week 24. The purpose of transplantation is either improvement of vision, repairing epithelial defects, or detaching ocular surface adhesion. The primary endpoints are the scores for changes in vision, changes in total epithelial abnormality scores, and conjunctival sac adhesion score for each purpose. | — |
Secondary
| Measure | Time frame |
|---|---|
| <Objective findings> Each item in ophthalmology findings A and B. <Safety Evaluation> Incidence rates and severities of adverse events. | — |
Countries
Japan
Contacts
Public ContactChie Sotozono, M.D., Ph.D.
Kyoto Prefectural University of Medicine Department of Ophthalmology
Outcome results
None listed