Clinical trial NCT02009709: Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2
Official title: Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Keratoconus
Corneal Ectasia
Keywords: keratoconus
collagen crosslinking
crosslinking
ectasia
Lead sponsor: Mack Eye Center
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.


Eligibility criteria: General Inclusion Criteria

Prospective subjects must meet all of the following criteria to be eligible for participation:

* 18 years of age or older
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits
* Contact lens removal prior to evaluation and treatment

Inclusion criteria for progressive keratoconus

Prospective subjects must meet two of the following criteria:

* Having a diagnosis of progressive keratoconus:
* An increase of ≥ 1.00 D in the steepest keratometry value
* An increase of ≥ 1.00 D in astigmatism manifest refraction
* A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
* Presence of central or inferior steepening on the Pentacam map.
* Axial topography consistent with keratoconus
* Steepest keratometry (Kmax) value ≥ 47.00 D

Inclusion criteria for ectasia

Prospective subjects must meet the following criteria:

* History of having undergone a keratorefractive procedure
* Meeting two of the following criteria
* Steepening by topography, either Pentacam or Humphrey
* Thinning of cornea
* Shift in the position of thinnest portion of cornea
* Change in refraction with increasing myopia
* Development of myopic astigmatism
* Development of irregular astigmatism
* Loss of best spectacle corrected acuity. 6.2 Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from this protocol:

* Eyes classified as either normal, atypical normal,
* Corneal pachymetry ≤ 350 microns at the thinnest point measured by Pentacam in the eye to be treated
* A history of chemical injury or delayed epithelial healing in the eye to be treated.
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment
* Inability to cooperate with diagnostic tests.
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
* Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
* Patients who are unable to remain supine and tolerate a lid speculum for an extended period of time.

Primary outcomes:
measure: Decrease in maximum corneal curvature
timeFrame: 3 and 6 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hoffman Estates
country: United States
facility: Mack Eye Center
state: Illinois
Study officials:
affiliation: Mack Eye Center
name: Robert J Mack, M.D.
role: PRINCIPAL_INVESTIGATOR
References: