Sachdev,Mahipal, Shetty,Rohit, Khamar,Pooja, Malik,Raghav, Schwam,Brian, Wang,Ying, Fu,Hong, Voorhees,Andrew, Laron,Michal, Sachdev,Mahipal, Shetty,Rohit, Khamar,Pooja, Malik,Raghav, Schwam,Brian, Wang,Ying, Fu,Hong, Voorhees,Andrew, and Laron,Michal
Mahipal S Sachdev,1 Rohit Shetty,2 Pooja Khamar,2 Raghav Malik,1 Brian L Schwam,3 Ying Wang,3 Hong Fu,3 Andrew P Voorhees,3 Michal Laron3 1Centre for Sight, New Delhi, India; 2Narayana Nethralaya Eye Hospital, Bangalore, India; 3Johnson and Johnson Surgical Vision, Inc, Milpitas, CA, USACorrespondence: Michal Laron, Johnson and Johnson Surgical Vision, Inc, 510 Cottonwood Drive, Milpitas, CA, 95035, USA, Tel +1 408 273 5802, Email mlaron@its.jnj.comPurpose: To evaluate visual outcomes following the Smooth Incision Lenticular Keratomileusis (SILKTM) procedure for correction of myopic refractive errors with and without astigmatism, using the ELITATM Femtosecond Laser System.Patients and Methods: A prospective, multicenter, single-arm, open-label clinical study was conducted. Eighty-five myopic subjects (n = 170 eyes), aged 18 years or older, with manifest refractive spherical equivalent (MRSE) up to â 12.00 D and astigmatism up to â 6.00 D, were treated binocularly using the ELITA femtosecond laser and followed up for 6 months. Intended correction was emmetropia for all eyes. The primary outcome measures included post-operative uncorrected and corrected distance visual acuity (UDVA and CDVA). Secondary outcome measures included surgeonâs rating for ease of lenticule extraction, predictability, safety, and stability.Results: A total of 170 eyes of 85 patients underwent SILK. Preoperative mean MRSE was â 4.14 D ± 1.32 D (range â 1.38 D to â 8.88 D) and the mean cylinder was â 0.77 D ± 0.62 D. Intraoperative surgeon ease of lenticule dissection was rated as grade 0 or 1 in 85.3% of eyes (no/only mild dissection needed). UDVA at 1 day, 1 week, 1 month, and 6 months was 20/20 or better in 65.9%, 85.4%, 91.5%, and 96% of eyes, respectively. No eyes lost any lines of CDVA at 6 months compared to the preoperative. The postoperative MRSE was stable over time, ranging from â 0.34 D ± 0.24 D at 1 month to â 0.33 D ± 0.23 D at 6 months. MRSE predictabilit