Clinical Outcomes Comparison of Combined Small Incision Lenticule Extraction with Collagen Cross-Linking Versus Small Incision Lenticule Extraction Only.

Purpose: To evaluate clinical outcome during 24 months follow-up between small incision lenticule extraction combined with cross-linking (SMILE Xtra) and small incision lenticule extraction (SMILE) only. Setting. Ophthalmology Division of San Rossore Medical Center, Pisa, Italy. Design: Retrospective comparative case series. Methods: The study comprised 70 eyes (35 patients); 40 eyes were corrected using SMILE and 30 eyes were corrected using SMILE Xtra using a low energy protocol. The outcomes were compared at 1, 6, 12, and 24 months postoperatively. Results: The mean spherical equivalent (SEQ) reduced from -7.18 ± 1.21 D to -0.01 ± 0.09 D in the SMILE group and from -6.20 ± 2.99 D to -0.04 ± 0.1 D postoperatively in SMILE Xtra (p < 0.05). At 24 months the mean SEQs were -0.01 ± 0.24 D for SMILE and -0.15 ± 0.33 D for SMILE Xtra (p > 0.05). At 1, 6, 12, and 24 months, there were no statistically significant differences between the SMILE and SMILE Xtra groups in logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA), safety, and efficacy index (p > 0.05). The mean average keratometry (K-avg) at 1, 6, 12, and 24 months after surgery did not shown any statistically significant difference between SMILE and SMILE Xtra group (p > 0.05). The mean maximum keratometry (K-max) readings at 1, 6, 12, and 24 months were not statistically significant between SMILE and SMILE Xtra group (p > 0.05). The preoperative mean thinnest point pachymetry (TTP) was 543.90 ± 22.85 µm in the SMILE group and 523.40 ± 37.01 µm in the SMILE Xtra group (p < 0.05). At 1, 6, 12, and 24 months the mean TTP was not statistically significant between the SMILE and SMILE Xtra groups (p > 0.05). At 24 months, the TTP was 408.29 ± 38.75 µm for the SMILE group and 402.22 ± 37 µm for the SMILE Xtra group (p > 0.05). In the preoperative period, the mean maximum posterior elevation (MPE) was 8.63 ± 4.35 µm for SMILE and 8.13 ± 2.54 µm for SMILE Xtra (p > 0.05). After the surgical procedure, both groups showed a statistically significant increase of the MPE (p < 0.05). At 24 months, the MPE was 11.00 ± 4.72 µm for SMILE Xtra and 10.14 ± 3.85 µm for the SMILE group (p > 0.05). In the preoperative period, the means of the root mean square (RMS) of high-order aberration (HOA) were 0.08 ± 0.03 µm for the SMILE group and 0.08 ± 0.03 µm for the SMILE Xtra group (p > 0.05). At 24 months, the RMS of HOA was 0.13 ± 0.07 µm for the SMILE group and 0.14 ± 0.07 µm for the SMILE Xtra group (p > 0.05). In the preoperative period, the root mean square of coma aberration (RMS-Coma) aberration was 0.06 ± 0.09 µm for the SMILE group and 0.04 ± 0.03 µm for the SMILE Xtra group (p > 0.05). At 24 months, the coma aberration of SMILE group was 0.12 ± 0.21 µm and 0.16 ± 0.25 µm for SMILE Xtra group (p > 0.05). Conclusions: SMILE Xtra procedure is a safe and simple procedure that can be offered to patients with high corneal ectasia risk because there were no differences in the indices of ectasia compared to the group treated only with SMILE which has a low corneal ectatic risk.

Emotional self-efficacy and alexithymia may affect compliance, renal function and quality of life in kidney transplant recipients: results from a preliminary cross-sectional study.

UNLABELLED: Recent studies show that alexithymia may influence compliance and quality of life in different clinical situations. The aim of this study was to evaluate the associations between alexithymia or emotional self-efficacy and compliance, quality of life (QoL) and renal function in renal transplant patients. METHODS: Forty-three patients were enrolled during a follow-up visit (>3 months post-transplant) and were asked to complete three self-report questionnaires (TAS-20, SF-36, RESE) to answer the following items: "In the past four weeks, how many times did you fail to take your prescribed dose?" and "How would you rate your adherence levels from 0 to 100?" (visual analogue scale). RESULTS: Alexithymia was positively correlated with non-compliance (r=.314; p=.04), and negatively with QoL dimensions. Analysis of variance confirmed that patients with high levels of alexithymia reported a negative perception of their QoL (mental health: F(1,41)=7,6; p=.008) and lower levels of compliance (F(1,41)=12,5; p=.001) compared with patients with low levels of alexithymia. The self-efficacy in the management of negative emotions was significantly correlated (r=-.314; p=.04) with creatinine levels and positively with the QoL (mental health: r=.421; p=.005). DISCUSSION: The inability to recognize and express emotions, as well as the ability to manage negative emotions, may influence compliance and QoL of renal transplant patients. Focused psychological support could be useful in these patients in order to increase their compliance and QoL.

Morphologic study of the cornea by in vivo confocal microscopy and optical coherence tomography after bifocal refractive corneal inlay implantation.

PURPOSE: To evaluate the biocompatibility of the Flexivue Microlens intracorneal inlay based on healing of corneal wounds and analysis of corneal structural features using in vivo confocal microscopy (IVCM) and anterior segment optical coherence tomography (AS-OCT). SETTING: Ophthalmology Department, Misericordia e Dolce Hospital, Prato, Italy. DESIGN: Case series. METHODS: The intracorneal inlay was inserted in a stromal pocket created in the nondominant eye of emmetropic presbyopic patients using a femtosecond laser. In vivo confocal microscopy and AS-OCT examinations were performed preoperatively and 1, 6, and 12 months postoperatively. RESULTS: The mean follow-up was 7.6 months. In the early postoperative period, IVCM showed intense cellular activity in the stroma around the inlay, edema, inflammation, and degenerative material deposition but normal regularity after 12 months. Anterior segment OCT showed a regular planar shape of the corneal pocket in all eyes. The mean of the side-cut angles was 30.7 degrees. The mean difference between the measured and planned pocket depth was 9.77 µm. At 1 month, hyperreflective areas beneath the inlay and microfolds were observed in 21 of the 52 eyes. After 12 months, the anterior segment profile was regular and interface pocket reflectivity decreased over time. Six patients had inlay removal postoperatively (3 before 6 months; 3 before 12 months); after removal, IVCM and AS-OCT showed clear corneas without signs of irregularity. CONCLUSION: In vivo confocal microscopy and AS-OCT analysis showed that the inlay elicited a low-level wound-healing response in its immediate vicinity with no alteration in the corneal structures. FINANCIAL DISCLOSURE: Dr. M. Fantozzi is a member of the Presbia medical advisory board. No other author has a financial or proprietary interest in any material or method mentioned.