Ugur Celik1, Nese Alagoz2, Yusuf Yildirim2, David Muller2, John Marshall2, Ahmet Demirok2, Omer Faruk Yilmaz2. 1. From Beyoglu Eye Training and Research Hospital (Celik, Alagoz, Yildirim, Yilmaz) and the Department of Ophthalmology (Demirok), Medeniyet University, Istanbul, Turkey; Avedro (Muller), Boston, Massachusetts, USA; the Institute of Ophthalmology (Marshall), London, United Kingdom. Electronic address: h.ugurcelik@gmail.com. 2. From Beyoglu Eye Training and Research Hospital (Celik, Alagoz, Yildirim, Yilmaz) and the Department of Ophthalmology (Demirok), Medeniyet University, Istanbul, Turkey; Avedro (Muller), Boston, Massachusetts, USA; the Institute of Ophthalmology (Marshall), London, United Kingdom.
Abstract
PURPOSE: To evaluate the safety and efficacy of a new microwave thermokeratoplasty procedure combined with accelerated corneal collagen crosslinking (CXL) to improve visual function in patients with keratoconus. SETTING: Cornea and refractive surgery department, Istanbul, Turkey. DESIGN: Prospective clinical trial. METHODS: Patients with keratoconus who had the combined procedure were evaluated over 12 months postoperatively. The main outcome measures were changes in logMAR uncorrected (UDVA) and corrected (CDVA) distance visual acuities and in keratometry (K) values. RESULTS: The study enrolled 24 eyes of 24 patients aged 18 to 45 years. The attempted corrections ranged from -1.60 to -6.50 diopters (D). The mean preoperative UDVA of 0.66 logMAR ± 0.26 (SD) significantly improved to 0.39 ± 0.21 logMAR 1 month postoperatively. However by 6 months, the mean UDVA had regressed to 0.58 ± 0.21 logMAR. At 12 months, the mean UDVA was 0.62 ± 0.17 logMAR. The mean K value was 49.11 ± 2.43 D preoperatively, 43.50 ± 3.04 D 1 month postoperatively, 47.52 ± 2.99 D at 6 months, and 48.37 ± 3.00 D at 12 months. There were no cases of significant endothelial cell loss or loss of CDVA lines at 12 months. CONCLUSIONS: The new thermokeratoplasty procedure followed by accelerated CXL produced the desired reduction in K values and improvement in postoperative UDVA without significant side effects. However, the early and complete regression of the thermokeratoplasty effect shows the need for further advancement of this technology. FINANCIAL DISCLOSURE: Drs. Yilmaz and Marshall are paid consultants to Avedro, Inc. Dr. Muller is president and CEO of Avedro. No other author has a financial or proprietary interest in any material or method mentioned.
PURPOSE: To evaluate the safety and efficacy of a new microwave thermokeratoplasty procedure combined with accelerated corneal collagen crosslinking (CXL) to improve visual function in patients with keratoconus. SETTING: Cornea and refractive surgery department, Istanbul, Turkey. DESIGN: Prospective clinical trial. METHODS:Patients with keratoconus who had the combined procedure were evaluated over 12 months postoperatively. The main outcome measures were changes in logMAR uncorrected (UDVA) and corrected (CDVA) distance visual acuities and in keratometry (K) values. RESULTS: The study enrolled 24 eyes of 24 patients aged 18 to 45 years. The attempted corrections ranged from -1.60 to -6.50 diopters (D). The mean preoperative UDVA of 0.66 logMAR ± 0.26 (SD) significantly improved to 0.39 ± 0.21 logMAR 1 month postoperatively. However by 6 months, the mean UDVA had regressed to 0.58 ± 0.21 logMAR. At 12 months, the mean UDVA was 0.62 ± 0.17 logMAR. The mean K value was 49.11 ± 2.43 D preoperatively, 43.50 ± 3.04 D 1 month postoperatively, 47.52 ± 2.99 D at 6 months, and 48.37 ± 3.00 D at 12 months. There were no cases of significant endothelial cell loss or loss of CDVA lines at 12 months. CONCLUSIONS: The new thermokeratoplasty procedure followed by accelerated CXL produced the desired reduction in K values and improvement in postoperative UDVA without significant side effects. However, the early and complete regression of the thermokeratoplasty effect shows the need for further advancement of this technology. FINANCIAL DISCLOSURE: Drs. Yilmaz and Marshall are paid consultants to Avedro, Inc. Dr. Muller is president and CEO of Avedro. No other author has a financial or proprietary interest in any material or method mentioned.