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Consistency, consistency, consistency: treatment standardization requirements for CXL

Poster Details

First Author: M.Mrochen SWITZERLAND

Co Author(s):    M. Friedman   P. Kamaev   M. Smirnov   G. Lytle   D. Muller        

Abstract Details

Purpose:

Treatment parameters that may contribute to outcome variability for corneal cross-linking (CXL) were investigated. Review of the clinical literature reveals significant variability in the response to CXL based on protocols, formulations, and equipment. A photochemical kinetics model of CXL was developed to determine the underlying mechanisms of the cross-linking process and examine the effects of different treatment parameters on cross-linking outcomes.

Setting:

Research Laboratory at Avedro Inc., Waltham MA USA

Methods:

A variety of treatment protocols for CXL reported in the clinical literature were evaluated for variability in clinical outcome, using such measures as the line of demarcation as observed on OCT. Treatment parameters, including method of riboflavin application, riboflavin formulation, illumination systems, UVA irradiance and dose, were simulated using the photochemical reaction models to evaluate the impact of these parameters on cross-linking outcomes and their sensitivity to variation. Predicted theoretical results were compared to clinical outcomes.

Results:

The photochemical reaction model reveals that small variations in the application of these treatment parameters, such as deviations in the application and duration of riboflavin induction, may result in substantial differences in the treatment outcome. These differences are reflected in the clinical literature, which reveals variability of as much as 40% in depth of demarcation line, for nominally equivalent clinical protocols.

Conclusions:

The findings of this evaluation reveal that inconsistency in surgical procedure will lead to variability in clinical outcomes. The results demonstrate the importance of precision in cross-linking treatment methodology. When reporting the results of clinical studies of the application of CXL, it is critical to report the exact and seemingly minor details of the surgical technique. Consistency, consistency, consistency.

Financial Disclosure:

One or more of the authors gains financially from product or procedure presented, One or more of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors receives consulting fees, retainer, or contract payments from a competing company, One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation, One or more of the authors has significant investment interest in a competing company, One or more of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented

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