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

Keratoconus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02009709
• Other study ID #: MEC-0001
• Status: Recruiting
• Phase: Phase 1
• First received: December 9, 2013
• Last updated: December 10, 2015
• Start date: October 2013

Study information

• Verified date: December 2015
• Source: Mack Eye Center
• Contact: Robert J Mack, M.D.
• Phone: 847-755-9393
• Email: rjsmack[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Ectasia
• Keratoconus

Intervention

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.

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
• 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.

Locations

Country	Name	City	State
United States	Mack Eye Center	Hoffman Estates	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Robert Mack, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in maximum corneal curvature		3 and 6 months post-procedure	Yes