Hoffman Estates, Illinois 60169

  • Corneal Ectasia

Purpose:

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.


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.


NCT ID:

NCT02009709


Primary Contact:

Principal Investigator
Robert J Mack, M.D.
Mack Eye Center

Robert J Mack, M.D.
Phone: 847-755-9393
Email: rjsmack@aol.com


Backup Contact:

N/A


Location Contact:

Hoffman Estates, Illinois 60169
United States

Adam Baruch
Phone: 847-755-9393
Email: adam@mackeyecenter.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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