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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Mack, M.D.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions; Riboflavin

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.