PURPOSE: To report the long-term clinical experience following femtosecond intrastromal lenticule implantation (FILI) for the management of moderate to high hyperopia. METHODS: Eligible patients who underwent FILI for moderate to high hyperopia from July 2013 to October 2020 were included. A donor small incision lenticule extraction lenticule, matched for refractive error, was implanted into the recipient's corneal pocket created using a femtosecond laser at 160 µm depth. Visual and refractive outcomes and long-term complications were evaluated at the end of a mean follow-up of 68 ± 17.28 months (5.6 years). RESULTS: Forty-two eyes of 25 patients (mean age: 27.29 ± 5.52 years) were analyzed. The mean spherical equivalent reduced significantly from +5.50 ± 1.96 to +0.66 ± 1.17 diopters (D) at last follow-up visit. Thirty eyes (71%) were within ±1.00 D of spherical equivalent correction. Cumulative uncorrected distance visual acuity of 20/40 or better was achieved in 34 eyes (81%). Efficacy and safety indices were 0.86 ± 0.19 and 1.17 ± 0.39, respectively. There was a significant increase in mean keratometry (Kmean) anterior, central corneal thickness, Q-value, and corneal higher order aberrations and a decrease in Kmean posterior 2 weeks postoperatively, without any significant change in these parameters thereafter ( P > .05). Four eyes of 3 patients underwent enhancement and another 4 eyes underwent explantation of the lenticule followed by exchange (2 eyes) and hyperopic laser in situ keratomileusis (2 eyes). No eye lost more than one line of CDVA. CONCLUSIONS: At 5 years of follow-up, FILI for moderate to high hyperopia showed good safety, efficacy, and reversibility. Modification of nomograms and surgical planning may be employed for further refinement of the outcomes. [ J Refract Surg. 2022;38(6):348–354.]
Purpose. To compare the long-term safety, efficacy, predictability, and refractive stability following SMILE versus SMILE combined with accelerated cross-linking (SMILE XTRA), and to specifically study the regression patterns following the two procedures. Methods. This retrospective study included 54 eyes of SMILE and 54 eyes of SMILE XTRA treated for normal and borderline cases of myopia/myopic astigmatism, respectively, based on certain predefined topographic features and risk factors. Patients in both the groups were matched for age and refractive error. The mean postoperative follow-up for the SMILE group was 22.18 ± 10.41 months and the SMILE XTRA group was 21.81 ± 10.19 months. Results. At the end of follow-up, the mean sphere, cylinder, and SE reduced to −0.03, −0.09, and −0.08 D in the SMILE group and −0.06, −0.15, and −0.13 D in the SMILE XTRA group. 96% and 93% eyes remained within ±0.50 D in SMILE and SMILE XTRA groups, respectively, and 94% eyes maintained an UDVA of 20/20 or better in the SMILE as well as SMILE XTRA groups. Safety and efficacy indices for the SMILE group were 1.03 and 1.00. For the SMILE XTRA group, the safety and efficacy indices were 1.00 and 0.99. No eye in either group had postoperative ectasia or enhancement performed for significant residual refractive error. Conclusion. Both the SMILE and SMILE XTRA groups exhibited comparable visual outcomes, safety, and efficacy. Contrary to the belief, combination of prophylactic CXL with SMILE did not result in a hyperopic shift in the long term. No eye in either group encountered postoperative ectasia; however, further follow-up is suggested to establish the long-term effects on refractive and corneal stability following SMILE XTRA, as all the eyes treated in this group were borderline.
PURPOSE: To evaluate the feasibility and report long-term outcomes with Bowman's membrane relaxation (BMR) for enhancing the residual refractive error following femtosecond intrastromal lenticule implantation (FILI). METHODS: BMR was performed using a Hessburg-Barron trephine to create a circular incision into the Bowman's membrane and anterior corneal fibers up to the depth of approximately 120 to 130 µm. After enhancement, clinical outcomes were analyzed for a mean period of 36 months (range: 14 to 57 months). RESULTS: Four eyes of 3 patients (mean age: 29 years) underwent enhancement with BMR for a significant residual refractive error of +2.25 diopters (D) spherical equivalent following FILI for high hyperopia (mean spherical equivalent: +7.00 D). After BMR, the residual refraction reduced to +0.31 D, resulting in improvement in uncorrected distance visual acuity from 0.55 to 0.33 logMAR. The mean front keratometry values increased from 46.20 to 49.30 D, and the mean back keratometry values increased from −5.90 to −6.30 D following BMR, the latter returning to the baseline (pre-FILI) value of −6.30 D. An increase in Q-value with a corresponding increase in higher order aberrations was observed. Corneal biomechanics indicated reduction of stiffness and other parameters after enhancement. No intraoperative or postoperative complications were noted. CONCLUSIONS: BMR may be an effective technique for enhancement of residual hyperopia following tissue addition techniques such as FILI. BMR may reverse the posterior curvature changes, negating the steepening effect of the anterior cornea following tissue addition, potentially aiding in the enhancement. [ J Refract Surg . 2022;38(2):134–141.]
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