Purpose: To assess the 3-year clinical results of the 18 mW 7 J/cm2 transepithelial enhanced fluence pulsed light M accelerated crosslinking in the treatment of progressive keratoconus (KC) with chemically enhanced hyper-concentrated riboflavin solutions without iontophoresis and with air-room oxygenation. Setting: Siena Crosslinking Center, Siena, Italy. Methods: Prospective pilot, open non-randomized interventional study including 40 eyes of 30 young adult patients over 21 years old (10 simultaneous bilateral) with early (Stage I and II) progressive KC undergoing TE-EFPL 18 mW/7 J/cm2 ACXL (EFPL M TECXL). The 12 min and 58 s pulsed light (1 s on/1 s off) UV-A exposure treatments were performed with a biphasic corneal soaking using Paracel I 0.25% for 4 min and Paracel II 0.22% for 6 min riboflavin solutions and New KXL I UV-A emitter (Glaukos-Avedro, Waltham, USA) at an air room of 21% oxygenation. All patients completed the 3-year follow-up. Results: CDVA showed a statistically significant improvement in the third postoperative month (Δ + 0.17 d. e.) with a final gain of +0.22 d. eq. AK showed a statistically significant decrease in the sixth postoperative month (Δ − 1.15 diopters). K itmax showed a statistically significant decrease at 1-year follow-up (Δ − 1.3 diopters). The coma value improved significantly by the sixth month (Δ − 0.54 µm). MCT remained stable during the entire follow-up. No adverse events were recorded. Corneal OCT revealed a mean demarcation line depth at 282.6 ± 23.6 μm. Conclusions: Transepithelial enhanced fluence pulsed light M accelerated crosslinking with chemically enhanced riboflavin solution halted KC progression in young adult patients without iontophoresis and no intraoperative oxygen supplementation addressing the importance of increased fluence.
Primary open angle glaucoma (POAG) is a worldwide disease with IOP being an important risk factor for the disease. Pharmacological and surgical treatments have been mainly targeted on lowering IOP by decreasing aqueous humor production or increasing aqueous humor outflow. Stem cell therapies may open new frontiers in regenerative ophthalmology branch. In POAG there is a strong association with pathologic degeneration of the trabecular meshwork (TM) and regenerative cell-therapy approaches have been focused mainly on modulation of the degeneration. Many different adult stem cell types have been discovered in different parts of the eye such as the corneal endothelium (CE) and anterior non-filtering portion of the TM called Schwalbe's ring region. These stem cells may supply new cells for the TM and may regenerate the TM structure thus reducing IOP and restore the homeostatic function of the eye. In this paper, we report the studies' latest findings and present our perspective on approaches that seem promising in the management of POAG.
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.
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