Functional Outcomes Of Silk - A New Intrastromal Lenticular Refractive Procedure -Interim Analysis

To evaluate the safety and efficacy of a new femtosecond laser platform Elita (Johonson & Johnson, Irvine, California, United States) in performing a novel intrastromal lenticular procedure SILK on European patients. The studied parameters were changes in UCVA, BCVA, corneal thickness, corneal topography, ocular wavefront in healthy young adults with preoperative BCVA of 20/20 or better. Data was collected preoperatively, on POD1, POW1 and POM1.

University Eye Hospital Svjetlost, Zagreb, Croatia 

Prospective, open-label, single-arm, clinical trial. The main outcome parameters were corrected andand uncorrected visual acuity for distance (CDVA/UDVA). Secondary outcome parameters are mean refractive spherical equivalent (MRSE), contrast sensitivity curve, ocular wavefront, and tomographic changes. Patient satisfaction and quality of vision was measured by means of questionnaires. All contrast and visual acuity testing was performed using the industry standard Automated ETDRS CTS suite (M&S Technologies, Niles, USA). 

We analysed 60 eyes from 30 patients. All eye achieved 20/25 or better UCVA. At all intervals checked no patients reported satisfactory vision and no need for glasses or contacts. Contrast sensitivity was excellent in all cases during photopic and mesopic conditions. Corneal thickness analysis showed great corelation to predicted values. 

Our early findings suggest great promise for Elita and Silk, with good efficacy and safety profiles, as well as high rates of patient satisfaction.  Given that this is an interim analysis, updated results with larger cohorts and longer follow-up data will be presented at a more advanced stage of the study.