HYPEROPIC RELEX SMILE

The aim is to evaluate the world first clinical results of laser kerato-lenticule extraction (KLEX) or the ReLEX Smile for hyperopia correction following the market release outside of the clinical study. 

Gemini Eye Clinic, Zlin, Czech Republic.

The first clinical data includes 18 eyes of 9 patients (5 male) with a median age of 44 years (41 to 57), who underwent hyperopia correction by corneal lenticule extraction the ReLEX Smile laser refractive surgery. Standard protocol used optical zone of 6.3 mm with a transition zone of 2 mm. Postoperative patients were given antibiotic and steroid eye drops Levofloxacin and combined Tobramycin and Dexamethasone 3 times a day.  Duri 3 months follow up subjective and objective refraction, monocular uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), monocular uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA) as well as slit lamp examination were evaluated. All values are presented as median and 25–75% interquartile ranges. 

The subjective spherical equivalent before the procedure was median +4.8 D (3.9; 5.3 IQR) and significantly decreased to 0.0 D (-0.75; 0.0) at 1W after surgery and 0.0 D (-0.44; 0.25) at 1M postoperatively. UDVA improved from a preoperative median of 0.30 logMAR (0.17; 0.60) to 0.16 logMAR (0.08; 0.37) and 0.18 logMAR (0.06; 0.28) at 1W and 1M, respectively. 88% of eyes achieved 0.3 logMAR and better at 1M. The median CDVA slightly worsened from 0.0 logMAR (0.0; 0.02) preoperatively to 0.12 logMAR (0.05; 0.23) at 1W and to 0.06 logMAR (0.02; 0.17) at 1M. There is a gradual recovery of CDVA as 4 eyes showed a loss of 2 lines at 1W, while at 1M there was only one eye with this loss. The median UNVA before surgery was J11 and at 1M all eyes read J1. DCNVA remained unchanged, with a median of J1. Slit lamp examination at 1W showed mild debris in 9 eyes (50%), mild haze in 2 eyes (11%) and corneal punctate epitheliopathy in 2 eyes (11%). At 1M the debris was observed in 3 eyes (16%), mild haze in 1 eye (6%).

The initial outcomes confirms that hyperopia correction with KLEX / ReLEX Smile is effective and safe. Longer follow-up on more patients across various sites is desirable to further evaluate this method.