A new technique to implant intracorneal ring-segments from the perilimbal region: one-year prospective pilot study report.

BACKGROUND: Recently a new surgical technique for intracorneal ring-segments (ICRS) assisted by femtosecond laser (FSL) called ByLimB was developed, involving the creation of the incision from a paralimbic region. This study aims to evaluate the safety and efficacy of the ByLimb technique following one year of follow-up. METHODS: A prospective, single-center study was conducted at the Zaldivar Institute in Buenos Aires, Argentina. Keratoconus patients with indication for ICRS-FSL assisted procedure, operated with the ByLimb technique were included. By using the ByLimb technique, the ICRS are placed without affecting the tunnel's roof, and the end of the ICRS is always away from the incision area. Visual acuity, topographic astigmatism, and the occurrence of complications were evaluated. Safety index was the main outcome and efficacy indes was a complimentary outcome. RESULTS: A total of 17 eyes completed the 12-month follow-up period. The safety index was 1.10 (mean postoperative corrected distance visual acuity (CDVA) in decimal: 0.76/preoperative CDVA: 0.69), while the efficacy index was 0.89 (mean postoperative uncorrected distance visual acuity UDVA in decimal: 0.62/preoperative CDVA: 0.69). Mean preoperative astigmatism was 5.3 ± 2.3, decreasing twelve months after surgery at 2.1 ± 1.2 (p < 0.001). No eye loss lines of vision and no intraoperative complications were observed. During the first month after surgery, an improper positioning of the ICRS based on topographic assessment was detected in five cases. A second procedure was performed, which consisted of opening the incision and introducing a Sinsky hook, through which the ICRS was mobilized and placed in its correct position. No incisional alterations, signs of infection, anterior segment anomalies, or fundus alterations were observed. CONCLUSION: FSL-assisted ICRS implantation through the perilimbal region has demonstrated an adequate safety index one year post-surgery. Additionally, this technique has facilitated accurate realignment of ICRS during secondary surgical interventions within one-month post-surgery. While the current findings are promising, continued follow-up of these cases is warranted.

ByLimb: Development of a New Technique to Implant Intracorneal Ring-Segments from the Perilimbal Region.

A new technique that allows implanting intracorneal ring-segments (ICRS) from the limbal zone is described. Using a femtosecond laser (FSL), a 360° corneal tunnel is created with an internal diameter of 5.4 mm and an external diameter of 7.0 mm, with a wider area (0.2 mm inner and 0.2 mm outer) in the upper 60° of the tunnel (called landing zone). Next, a 4.36 mm-long corneal-limbal incision was created with the FSL, which connects to the bubbles created in the landing zone. The entire procedure was performed using intraoperative optical coherence tomography (OCT). Once the two incisions were connected using blunt-edged Mac Pherson forceps, the bubbles were released from the surgical plane. The programmed ICRS(s), 6 mm in diameter, are then placed in the corneal tunnel from the limbal incision with the aid of Sinskey forceps. Finally, when the ICRS is in place, the surgery is complete.

Visual Acuity Improvement in Low, Moderate and High Myopia After Posterior-Chamber Phakic Implantable Collamer Lens Surgery in a Large Patient Cohort.

Purpose: To compare best-corrected visual acuity (BCVA) before and after implantable collamer lens (ICL) surgery in patients with low, moderate and high myopia. Methods: A single-centre, prospective, registry-based study involving patients with myopia who received ICLs between October 2018 and August 2020. The study population was divided into three groups of subjects with low (from 0 to -6 D), moderate (-6 to -10 D) and high myopia (more than -10 D). We analysed uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical equivalent (SE), differences between BCVA pre- and 1-month postoperative, and line gain in BCVA 1 month after surgery. Results: A total of 770 eyes belonging to 473 patients were surgically intervened during the study period, of which 692 eyes completed 1 month of postoperative follow-up and were included in the study population. At 1-month follow-up, 478 eyes (69%) achieved a BCVA of 20/20, 599 (87%) obtained 20/25 or better, and 663 (96%) had a BCVA of 20/40 or better. We identified a significant improvement in BCVA (baseline 0.15±0.2 logMAR vs follow-up 0.07±0.2 logMAR, p<0.0001) and a significant reduction in SE (baseline -9.23±4.1 D, vs follow-up -0.21±0.8 D, p<0.0001), with a significant relationship between preoperative SE and line gain (r = -0.46, p<0.0001). We identified a significantly higher line gain among eyes with higher degrees of myopia (low myopia 0.22±0.69 lines compared to moderate myopia 0.56±1.1 lines and high myopia 1.51±1.9 lines, p<0.0001). Notably, 99.6% of eyes with a high grade of myopia achieved improvement to a low degree (less than -6 D) at follow-up. The safety and efficacy indexes were 0.083±0.1 and -0.001±0.1, respectively. Conclusion: In this large patient cohort, ICL surgery was related to a significant line gain in BCVA, particularly among eyes with higher degrees of myopia.

Descriptive Analysis of Footplate Position After Myopic Implantable Collamer Lens Implantation Using a Very High-Frequency Ultrasound Robotic Scanner.

Purpose: To assess the position of the haptics of the implantable collamer lens (ICL) in myopic eyes using a high-frequency ultrasound robotic scanner. Methods: This was a prospective, single-arm, observational study carried out at the Instituto Zaldivar SA (Mendoza, Argentina) in a sample of 52 eyes who have been submitted to successful ICL implantation prior to enrollment. Images of the eyes were obtained using a very-high frequency digital ultrasound robotic scanner (VHFDU) to establish the position of the ICL in the posterior chamber and its relation to the ciliary sulcus. New parameters for lens position analysis were also described. Results: In 81% of cases (42 eyes), the ICL rests on the ciliary body (CB) in both temporal and nasal sides, being slightly lower than 6% (3 eyes) those that rest on the sulcus in both sides, with significant correlations between ICL position and vault values (p<0.05). Cases in which the ICL position was CB-CB yielded central vault values across the whole range determined within the sample, but most of the eyes where the ICL rests on both the sulcus in one side and the CB in the other yield greater central vault values. Correlation was significant between ICL position and retroposition distance on the temporal side (Spearman's rho -0.487, p<0.001). A significant but weaker correlation was also found between ICL position and retroiridian space (p<0.05). Conclusion: ICL for myopia footplates tend to locate outside of the sulcus in a significant percentage of patients after successful implantation. VHFDU assessment in eyes implanted with an ICL to properly study the lens footplate position and posterior anatomical relations provides important additional information besides post-surgery vault.

Efficacy of Intrastromal Corneal Ring Segments Combined With Flash Collagen Cross-Linking in Keratoconus.

PURPOSE: To evaluate outcomes, efficacy, and safety of intrastromal corneal ring segment implantation for treatment of keratoconus combined with collagen cross-linking (CXL) with 1-year follow-up. METHODS: One hundred nineteen eyes of 82 patients with keratoconus (37 females) underwent femtosecond (Intralase FS; Abbott Medical Optics, Inc) laser-assisted intrastromal corneal ring segment implantation (INTRASEG; Gamma Vision) with flash CXL (18 mW/cm for 5 minutes). The outcome measures were uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), subjective refractive error, keratometry values, and corneal thickness. RESULTS: Mean age of patients at implantation was 31 years (range 12-63, SD 9.5). According to the Amsler-Krumeich scale of keratoconus severity, 62 eyes were type 1 (52%), 43 eyes, type 2 (36%), and 14 eyes, type 3 (11.8%). Statistically significant improvement of UDVA/CDVA and reduction in the mean cylinder and mean keratometry at 1 year were observed. Mean UDVA (logMAR) was 1.11 ± 0.61 (SD) preoperatively and 0.54 ± 0.58 (SD) postoperatively (P < 0.001). Mean CDVA was 0.52 ± 0.18 (SD) preoperatively and was 0.14 ± 0.17 (P < 0.0001) postoperatively. Preoperative Kmax was 48.75 diopters (D) (range 41.0-55.0 D), and postoperative Kmax was 46.18 D (P < 0.0006); preoperative Kmin was 44.69 D (SD) 3.59 and postoperative Kmin was 43.00 D (SD) 2.53. The mean cylinder was -5.19 D preoperatively (range -0.80 to -8.80 D) and -2.6 D (range -1.00 to -7.25) postoperatively. Mean corneal pachymetry was 486.6 µm (range 391-591). No intraoperative complications occurred. No patient lost any lines of UDVA or CDVA. CONCLUSIONS: Implantation of the INTRASEG with the Intralase combined with flash CXL was apparently safe and effective in treatment of keratoconus. The variety of options in thickness and arc length of the segments enables more precise correction of keratoconus and refractive errors.