Keratoconus, Keratoectasia
Conditions
Interventions
corneal crosslinking with removal of corneal epithelium
corneal crosslinking without removal of corneal epithlium
Sponsors
the University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those whose age at obtaining informed consent meet following criteria Keratoconus: 14 years old and more Keratoectasia: 20 years old and more 2) Those whose diagnosis by corneal topography is keratoconus, keratoconus suspect or keratoectasia 3) The thinnest corneal thickness is over 400 micron meter. In the case that corneal thickness is less than 400 micron meter, it is necessary of more than 400 micro meter of corneal thickness during surgery after adding hypotonic riboflavin solution. In case without removal of corneal epithelium, the criteria is more than 380 micro meter of corneal thickness. 4) Progressive keratoconus or keratoectasia meeting any of the following criteria; -the maximum corneal refractive power (Kmax) increases of more than 1 diopter -manifest astigmatism increases of more than 1 diopter -manifest spherical equivalent increases more than 1 diopter -base curve of hard contact lenses decreases of more than 0.1mm 5) In case of keratoconus, no history of acute hydropes 6) In case of keratoectasia, those who have a history of refractive surgery such as LASIK 7) Patients whose voluntary consent document was obtained after receiving enough explanation about this study 8) Outpatient
Exclusion criteria
Exclusion criteria: 1)Those undergoing drug therapy for such as glaucoma, more than moderate dry eye or allergy 2)those with ocular disease such as uveitis 3)those with systemic disease that can affect wound healing, such as diabetes 4)Those without obvious progression of the disease for a year before sugery 5)Those with corneal melting disase 6)Those without lens 7)Those with intraocular lens which have no protective function against ultraviolet 8)Woman who are or might be pregnant 9)Lactating woman 10) Those who received other investigational clinical trials within 3 months before the beginning of this study 11) Patients who are judged to be unsuitable as a subject by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected and best corrected visual acuity, maximum corneal refractive power in corneal topography | — |
Secondary
| Measure | Time frame |
|---|---|
| corneal thickness measured by anterior segment OCT | — |
Countries
Japan
Contacts
Public ContactTomohiko Usui
the University of Tokyo Hospital Department of Ophthalmology
Outcome results
None listed