Purpose:

To evaluate the clinical outcomes of precision shaped lenticules comprised of sterile allograft corneal tissue for hyperopia correction.

Methods:

This prospective study included 16 patients (28 eyes). Hyperopic corneal lenticules (Transform, Allotex Inc boston, USA) are implanted after femtosecond laser (iFS 150kH, Intralase, Abbott Medical Optics, Santa Ana, CA, USA) assisted flap creation. The corneal inlay was carefully transferred onto the exposed stromal bed by means of a loop like instrument using a meniscus technique under a surgical microscope of a clincial excimer laser (Visix S4, CustomVue S4IR Abbott Medical Optics Inc., Santa Ana, CA, USA). Manifest and cycloplegic refraction, uncorrected distance visual acuity (UCDVA), uncorrected near visual acuity (UCNVA), best corrected distance visual acuity (BCDVA),best corrected near visual acuity (BCNVA) were measured preoperatively and 3 months postoperatively.

Results:

The mean preoperative UCDVA(logMAR) in the treatment eye was 0,55±0,34 and was significantly increased to 0,22± 0,20 (p<0.001) at="" the="" three="" month="" follow-up.="" there="" was="" no="" significant="" change="" between="" mean="" preoperative="" bcdva="" (logmar)="" of="" 0,14±0,20="" and="" bcdva="" of="" 0,20±0,25="" postoperatively="" (p="">0.05). The mean preoperative pachymetry was 557±43,00 and was increased to 608±60,80 microns. The mean preoperative mean K was 42,62±0,82 D and was increased to 45,91±2,06 D. Postoperative refraction in 88,5% of eyes had within ±1,00 D .

Conclusions:

Preliminary results indicate that the sterile hyperopic allograft lenticules enhance visual performance of patient . Larger clinical studies are needed to demonstrate the effectiveness and safety with long term follow-up.