Clinical trial NCT03245853: Epi-On Corneal Crosslinking for Keratoconus
Official title: Epithelium-On Corneal Collagen Crosslinking for Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratoconus
Keratoconus, Unstable
Keywords: Keratoconus
Corneal Crosslinking
CXL
Lead sponsor: Comprehensive EyeCare of Central Ohio
Sponsor class: OTHER
Collaborators: name: Glaukos Corporation
First posted: 2017-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo required screening testing. Informed consent will be obtained from each subject prior to study-oriented testing.
Primary purpose: TREATMENT

Brief summary: Epithelium-On Corneal Crosslinking for Keratoconus.

Detailed description: Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination.

The primary efficacy parameter is the change from baseline over time in maximum keratometry (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA).

Eligibility criteria: Inclusion Criteria:

* 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to become pregnant, or lactation during study. Corneal pachymetry \<350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.

Nystagmus or any other condition that would prevent steady gaze. Other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.

Primary outcomes:
measure: Maximum keratometric change
timeFrame: 12 months
Secondary outcomes:
measure: Visual acuity change
timeFrame: 12 months
Other outcomes:
Locations:
city: Westerville
country: United States
facility: Comprehensive EyeCare of Central Ohio
state: Ohio
Study officials:
affiliation: Comprehensive EyeCare of Central Ohio
name: Kenneth A Beckman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: