Comparison of of two pharmaceutical products of Riboflavin for keratoconus
Not Applicable
- Conditions
- Keratoconus.Keratoconus
- Registration Number
- IRCT201212034333N2
- Lead Sponsor
- oor Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
The inclusion criterion is the clinical diagnosis of progressive keratoconus with paraclinical confirmation. The criteria of progressive keratoconus is an increase of at least 1D in maximum keratometry, astigmatism, or manifest refraction, or loss of 2 best corrected visual acuity (BCVA) lines or more in the past 12 months. Patients aged 15-35 years old with keratometry less than 55D and a central corneal thickness less than 400 µ will be selected for the study. Patients with other ocular diseases or a history of ocular surgery will be excluded from the study. Participants discontinue the use of the hard and soft contact lens 3 weeks and 3 days prior to the surgery, respectively.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual acuity. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: Snellen chart.;Refraction. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: retinoscope.;Corneal topography. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: pentacam.;Corneal rigidity. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: ORA.;Endothelial cell count. Timepoint: pre operative and 1, 3, 6, and 12 months after the procedure. Method of measurement: non-contact specular microscope.
- Secondary Outcome Measures
Name Time Method Corneal Haze. Timepoint: 1, 3, 6, and 12 months after surgery. Method of measurement: Opthalmic examination.