Patients with ocular sequelae due to Stevens-Johnson syndrome(SJS)
Conditions
Interventions
Use of the limbal-supported CL
Sponsors
Kyoto Prefectural University of Medicine
Kyoto university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Being diagnosed with keratoconjunctival disease due to SJS (2) BCVA is upper than or equal to 0.01 less than 0.7 (3) Less than 5mm with Schirmer's tear test I (4) Being 20 years of age or older and younger than 76 years of age at the time of recruit (5) Patients treated as an outpatient (6) Patients from whom written informed consent is obtained
Exclusion criteria
Exclusion criteria: (1) Patients who are beleived to be inappropriate due to complications below; - An acute or sub-acute inflammation of anterior eye part - An active corneal infection - An uveitis (2) Patients who are hypersensitive to fit CL (3) Patients who are believed to be exposed to dust and chemical drug with eyes (4) Patients who are believed to have trouble with fit CL (5) Patients performed ocular operations (such as cataract surgery, surgery of glaucoma treatment, corneal transplantation and so on) within latest 3 months (6) Patients for whom it has been determined by the medical doctors that there will be complicating issues with the patient participating in the clinical trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome measure is over LogMAR 0.2 improvement rate of bestcorrected visual acuity(BCVA) at before CL fitting and at after 3 months use of the limbal-supported CL post fitting | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change value of bestcorrected visual acuity(BCVA) at before CL fitting and at after 3 months use of the limbal-supported CL post fitting (2) Change value of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) composite score (3) Change severity of pain and dryness in the eye (VAS scale) (4) 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