Trial | NCT02009709  Report issue

Title

Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    riboflavin ...

  • Study Participants

    100
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.
Study Started
Oct 31
2013
Primary Completion
Jan 31
2017
Anticipated
Last Update
Dec 14
2015
Estimate

Drug Riboflavin 0.1% ophthalmic solution

Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.

  • Other names: CXL, CCL, crosslinking

Device CCL-VARIO UV lamp

Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes

  • Other names: CXL, CCL, crosslinking

Device CCL-VARIO at 18 mW/cm2

Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.

  • Other names: CXL, CCL, crosslinking

9 mW/cm2 Active Comparator

CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

18 mW/cm2 Active Comparator

CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution

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.
No Results Posted