keratoconus
Conditions
Interventions
treatment group:photorefractive intrastromal cross-linking (PiXL)
Sponsors
Eye and ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Be at least 18 years of age, male or female, of any race; 2. Provide written informed consent; 3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 4. Diagnosed as keratoconus; 5. Having BCVA of 20/80 or better; 6. Having refractive error meeting the criteria MRSE 0 to -3.00 D, with cylindrical component pl to -2.0 D; 7. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation TimeSoft 1 WeekSoft Extended Wear 1 WeekSoft Toric 2 WeeksRigid gas permeable 2 Weeks.
Exclusion criteria
Exclusion criteria: 1. Contraindications to the use of the test article(s); 2. A known allergy to the test article(s) or their components; 3. Corneal pachymetry that is <475 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated; 4. Eyes which are aphakic; 5. Eyes which are pseudophakic without the presence of a UV blocking posterior chamberintraocular lens (PCIOL); 6. Eyes which are pseudophakic with an anterior chamber intraocular lens (AC IOL); 7. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.), except keratoconus. b. Clinically significant corneal scarring in the cross-linking treatment zone that in the investigators opinion, will interfere with the cross-linking procedure; c. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated; 8. Pregnancy (including plans to become pregnant) or lactation during the course of the study; 9. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests; 10. Patients with a current condition that, in the investigators opinion, would interfere with or prolong epithelial healing; 11. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment. 12. A history of the insertion of Intacs in the eye to be treated or previous corneal surgery other than cataract extraction with PCIOL implantation; 13. A history of cataract extraction occurring within the three months prior to study treatment. Note: In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity;manifest refraction spherical equivalent;corneal curvatur; | — |
Secondary
| Measure | Time frame |
|---|---|
| Slit Lamp Examination; | — |
Countries
China
Contacts
Public ContactXingtao Zhou
Eye and ENT hospital of Fudan University
Outcome results
None listed