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Evaluation of transepithelial corneal collagen cross-linking (CXL) at 6 months and 1 year follow-up in patients with different proprietary transepithelial riboflavin solutions

Poster Details

First Author: R.Rubinfeld USA

Co Author(s):    W. Trattler   R. Littner   R. Correa   J. Alvarez   D. Adrian   G. Perez

Abstract Details



Purpose:

Transepithelium corneal cross linking has been reported to be ineffective. The Purpose of this analysis was to evaluate the safety and efficacy and corneal stromal loading times of two proprietary formulations of tranepithelial riboflavin- Formulation 1 and Formulation 2 to demonstrate efficacy and compare operative procedure time relative to standard crosslinking in a clinical setting.

Setting:

The study was conducted at a 2 separate clinics in the United States, one in Chevy Chase, Maryland, and the second in Miami, Florida

Methods:

Patients with a diagnosis of keratoconus or post-Lasik ectasia who had undergone Transepithelial CXL in one or both eyes were included in this analysis. Patients with previous RK, INTACS, repeat CXL procedures, and/or patients who were pseudo-phakic or had a diagnosis of cataract were excluded from this analysis. Outcome measures included intraoperative transepithelial corneal stromal riboflavin loading times, and UCVA, BSCVA, and K Max at 6 months and 1 year follow up visits. Corneal stromal loading was assessed by slit lamp examination.

Results:

Patients treated with riboflavin formulation 1 had a higher range and longer average riboflavin loading time than patients treated with riboflavin formulation 2. 199 eyes were treated with proprietary riboflavin formulation 1. The average loading time was 56.3 minutes. 127 eyes were treated with proprietary riboflavin formulation 2. The average loading time was 22.17 minutes. Visual outcome results were comparable at 6 months and 1-year follow up in both groups. A remarkable flattening in K max was noted at 6 month and 1-year follow-up visits in eyes treated with proprietary formulation 2. At 6 months post-CXL, 52% and 52% of eyes (formulation 1) and 45% and 47% of eyes (formulation 2) improved 1 or more lines in UCVA and BSCVA from pre-Op. Patients treated with formulation 1 and formulation 2 experienced 0.24D flattening and 1.36D in K Max, respectively, at 6 months follow-up. At 1 year follow up, 59% and 55% of eyes (formulation 1) and 63% and 50% of eyes (formulation 2) experienced 1 or more lines of improvement in UCVA and BSCVA. Patients treated with formulation 1 and formulation 2 experienced 0.52D flattening and 2.00D flattening, respectively, in K max from Pre-Op.

Conclusions:

The efficacy of trans-epithelium corneal cross linking depends on the formulation and the application of the solution. The presented results demonstrate that trans- epithelium cross linking with an appropriate formulation can provide an efficacy that is comparable to the epi-off Dresden protocol without substantial increase in the loading time. FINANCIAL INTEREST: One of more of the authors... has significant investment interest in a company producing, developing or supplying product or procedure presented

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