This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
550
1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.
Center for Sight
Sacramento, California, United States
Mean change in corneal curvature
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
Time frame: Baseline, 6 Months, and 12 Months
Change in manifest refraction spherical equivalent
Change in refraction
Time frame: Baseline, 6 Months, and 12 Months
Change in best-corrected visual acuity (BSCVA)
Percentage of eyes that had a loss of 2 or more lines in BSCVA
Time frame: Baseline, 6 Months, and 12 Months
Change in uncorrected-visual acuity (UCVA)
Time frame: Baseline, 6 Months, and 12 Months
Change in thinnest pachymetry
measured by ultrasound
Time frame: Baseline, 6 Months, and 12 Months
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