JPRN-jRCTa031210199
Recruiting
未知
Exploratory clinical study to examine safety and efficacy of iPS cell-derived corneal endothelial cell substitutes for bullous keratopathy - CLS001
Hirayama Masatoshi0 sites3 target enrollmentJuly 15, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Bullous keratopathy
- Sponsor
- Hirayama Masatoshi
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) A diagnosis of bullous keratopathy after corneal transplantation, including at least one previous penetrating keratoplasty.
- •2\) Forty five years of age or older and under 85 years of age at the time of consent acquisition (male or female)
- •3\) A central corneal endothelial cell density of less than 500 cells/mm^2 measured by specular microscope or confocal microscope, or undetactable.
- •4\) Voluntary written consent to participate in the study.
Exclusion Criteria
- •1\) Patients with undiagnosed keratoconjunctival disease.
- •2\) Central corneal thickness of 1200 micro meter or blood vessel invasion in the stroma of cornea.
- •3\) i) Active corneal infection OR ii) Active systemic infections (bacteria, fungi, positive in viral test such as hepatitis B virus, hepatitis C virus, etc.).
- •4\) IOP \>\= 30 mmHg or even with glaucoma drugs administration IOP \>\= 21 mmHg
- •5\) Diabetes that it difficult to control(HbA1C 8\.0% or higher).(This can be omitted in the primary verification of eligibility.)
- •6\) Neovascularization in the iridocorneal angle or after neovascular glaucoma treatment.
- •7\) Medical history of hypersensitivity to anesthetic(xylocaine injection solution), antibiotics(levofloxacin ophthalmic solution),steroids(sanbetason ophthalmic and otorhinologic solution 0\.1%, flumetholon ophthalmic suspension 0\.1%),glaucoma treatment(prostaglandin analog, beta inhibitor,azopt otorhinologic solution, glanatec otorhinologic solution and so on),used during perioperative and postoperative observation.
- •8\) Scheduled to undergo internal eye surgery during the study.
- •9\) Medical history of cancer
- •10\) Presence of significant hepatic failure (with either AST or ALT higher than 100 IU/L).(This can be omitted in the primary verification of eligibility.)
Outcomes
Primary Outcomes
Not specified
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