Journal of cataract and refractive surgery最新文献

Purpose: To compare intraindividually the incidence and intensity of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates between 2 similar open-loop single-piece hydrophobic acrylic intraocular lenses (IOLs) differing slightly in their particular material, optic surface, and sharp posterior edge design over a period of 3 years.

Setting: Department of Ophthalmology, Medical University Vienna, Vienna, Austria.

Design: Randomized, prospective, patient-masked and examiner-masked clinical trial with intraindividual comparison.

Methods: 100 patients randomly received a Vivinex XY1 IOL in 1 eye and a Clareon CNA0T0 IOL in the fellow eye. The amount of PCO (score 0 to 10) was assessed subjectively and objectively with digital retroillumination pictures using automated image analysis software (Automated Quantification of After-Cataract). Corrected distance visual acuity and the presence of glistenings, subjective visual symptoms, and Nd:YAG laser capsulotomy rate were noted.

Results: 67 of 100 patients were available for the 3-year follow-up examination. The objective PCO score of the Vivinex XY1 IOLs was 1.0 ± 1.0 compared with the PCO score of 1.5 ± 1.2 for the Clareon CNA0T0 IOLs ( P < .001). 7.5% of patients had a Nd:YAG capsulotomy in the Vivinex XY1 eye, and 9.0% had a capsulotomy in the Clareon CNA0T0 eye ( P = 1.0).

Conclusions: Both hydrophobic acrylic IOLs showed low PCO and YAG rates with a small but significant favor of the Vivinex XY1 IOL compared with the Clareon CNA0T0 IOL. The interaction of various factors such as hydrophobic material, smooth optic surface, and sharp posterior optic edge is the major key for PCO prevention.

Clinical trial number: NCT04369482.

Purpose: To analyze waste from intraocular lens (IOL) packaging across a variety of brands.

Setting: Private clinical practice.

Design: Prospective weight and composition analysis of all elements of unopened packages of IOLs sold in the United States-both preloaded and non-preloaded.

Methods: Samples were collected from multiple IOL companies in 2023. The primary end point for comparison was the total weight of each IOL package, because this generally correlates with the carbon footprint. The percentage of total weight contributed by paper, plastic, Tyvek, foil, sterile saline solution (fluid), metal, or glossy paper material was also calculated.

Results: The non-preloaded IOL package weights ranged from 29 g (Zeiss Lucia) to 80 g (RxSIGHT LAL). Most of the weight was attributable to paper, including the box and instructions for use (IFUs) pamphlet. The latter was generally the largest component within the box. The weights of preloaded IOL packages were generally higher than those of their non-preloaded counterparts and ranged from 67 g (Hoya iSert) to 116 g (Rayner RayOne Spheric).

Conclusions: Meaningful differences in IOL packaging weight and waste were noted across different models and manufacturers. Electronic IFUs linked to QR codes could replace the need for an IFU pamphlet within every box, significantly reducing the box's size, weight, and carbon footprint. Pairing preloaded IOL cartridges with autoclavable injectors could reduce associated waste. Because of the enormous global volume of IOL implantation, these waste-reducing strategies should be prioritized by IOL manufacturers.

Purpose: To investigate whether standard keratometry (K) or total corneal power (TCP) leads to more accurate refractive outcomes for intraocular lens (IOL) power calculation.

Setting: Public hospital.

Design: Retrospective evaluation of a diagnostic test instrument.

Methods: Preoperatively, all patients underwent optical biometry with Anterion, a swept-source optical coherence tomography device providing both K and TCP. The same IOL model was implanted in all cases. The whole sample was divided into a training dataset, used to optimize the formula constants, and a testing dataset, used to investigate the spherical equivalent prediction error (SEQ-PE) of 8 IOL power formulas. Trueness, precision, and accuracy were evaluated by means of the robust 2-sample t test. Cochran Q test was performed to assess whether the percentage of eyes with an SEQ-PE within each threshold was significantly different; in such an event, the McNemar test was then applied.

Results: Both the training and testing datasets included 317 eyes. No significant differences were detected for trueness because of constant optimization. Precision and accuracy were better when K was entered, although a statistically significant difference was observed only with the EVO (precision: P = .02 and accuracy: P = .03) and Haigis ( P < .01 for both precision and accuracy) formulas. No significant differences were observed for the percentage of eyes with an absolute SEQ-PE within any threshold.

Conclusions: With most formulas, IOL power calculation is not more accurate when TCP is used instead of K.

Purpose: To assess the power profile and optical performance of 2 extended range-of-vision (ERV) intraocular lenses (IOLs), TECNIS Eyhance (ICB00) and LuxSmart, and compare them with their monofocal counterpart lenses with similar platforms and materials: TECNIS 1-piece (ZCB00) and LuxGood, respectively.

Setting: Optics and Optometry Faculties of Complutense University (Madrid) and Universitat Politècnica de Catalunya BarcelonaTech (Terrassa) in Spain.

Design: Laboratory investigation on optical bench.

Methods: For each design, the power distribution and (fourth and sixth-order) spherical aberration (SA) across the lens aperture were measured as well as the optical performance using modulation transfer function-based metrics with through-focus evaluation. 3 nominal powers (+10.00 diopters [D], +20.00 D, and +30.00 D) and 3 pupil sizes (2.0 mm, 3.0 mm, and 4.5 mm) were considered to assess whether the base power of the lens and pupillary dynamics have an influence on the depth-of-focus extension.

Results: TECNIS Eyhance and LuxSmart IOLs had different power and SA profiles, but both designs shared a positive add power in their central region in comparison with their monofocal counterparts. LuxSmart had a greater add power while TECNIS Eyhance showed higher peak optical quality but smaller depth of focus.

Conclusions: Differences of focus extension between the 2 ERV IOL designs are related to differences of power and SA profile. The nominal base power of the IOLs has little effect on their optical quality. However, pupil dynamics plays a key role since it determines the effective add power and optical performance of the ERV IOLs.

Purpose: To explore the severity of posterior capsule opacification (PCO) using objective detection techniques and its relationship with visual acuity.

Setting: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.

Design: Prospective cohort study.

Methods: All patients underwent slitlamp examination, intraocular pressure (IOP) measurement, and corrected distance visual acuity (CDVA) testing before Nd:YAG laser capsulotomy, and examination, after fully dilated, with: IOLMaster 700, optical coherence tomography (OCT), Sirius Topographer (CSO) anterior segment analysis, and color fundus photography (CFP). CDVA and IOP were taken post treatment. Thickness and density of the posterior capsule, CFP quality (CFPQ) and OCT signal strength (OCTSS) were recorded. Analysis used Spearman correlation, heatmaps, and receiver operating characteristic curves.

Results: 83 eyes in 78 patients were included in this study. Spearman correlation analysis revealed correlations between pretreatment CDVA and IOLMaster 700 PCO thickness (MT), IOLMaster 700 cumulative effect (MCE), Sirius PCO thickness (ST), Sirius maximum density (SMD), Sirius cumulative effect (SCE), OCTSS, and CFPQ (correlation coefficients were 0.500, 0.484, 0.465, -0.256, 0.317, -0.442, -0.412, all P < .05). The improvement of vision acuity (ImpVA) showed correlations with MT, MCE, ST, SCE, OCTSS, and CFPQ (correlation coefficients were -0.452, -0.471, -0.346, -0.278, 0.320, 0.381, all P < .05). For ImpVA, the predictive ability of IOLMaster 700 was superior to Sirius, and the joint model was significantly better than single factors.

Conclusions: Posterior capsule thickness and cumulative effect were reliable indicators for evaluating PCO. Compared with Sirius, the IOLMaster 700 demonstrated superior predictive ability and higher correlation.

Purpose: To evaluate the effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared with a commercially available hydrogel canalicular plug (Form Fit).

Setting: 5 sites in the United States.

Design: Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug).

Methods: Adults (≥22 years) with the Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was noninferiority of the mean within subject change from baseline to month 3 in Schirmer score for patients receiving filler compared with plugs. The key secondary effectiveness endpoint was noninferiority of the proportion of patients with filler achieving improvement from baseline to month 3 in OSDI by a minimal clinically important difference. Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear breakup time, and safety.

Results: 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was noninferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI.

Conclusions: Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

Purpose: To evaluate microbiological cultures of cataract surgical devices and products that were reused for multiple cases.

Setting: Aravind Eye Hospital, Pondicherry, Tamil Nadu, India.

Design: Prospective cohort study.

Methods: Samples from multiple surgical instruments and products that were reused for consecutive cataract surgeries underwent bacterial and fungal cultures and were monitored alongside positive controls for 7 days. This included instruments that were processed using immediate use steam sterilization (IUSS) between cases (eg, surgical cannulas, syringes, phacoemulsification and coaxial/bimanual irrigation/aspiration [I/A] tips, phacoemulsification and I/A sleeves) (Group 1), instruments that were used without sterilization between cases (eg, phacoemulsification tubing/handpieces, coaxial I/A handpieces) (Group 2), and the residual (unused) fluid from balanced salt solution bags after being used for multiple patients (Group 3).

Results: 3333 discrete samples were collected from all 3 product groups that were reused across multiple patients. In all collected samples, no bacterial or fungal growth was observed. Of the 3241 cataract surgeries that used reused and IUSS-sterilized instruments alongside instrument sets cultured on the same day and balanced salt solution bags shared across multiple patients, no eyes developed endophthalmitis over a 6-week follow-up period.

Conclusions: Bacterial or fungal growth was not found in extensive microbiological cultures of IUSS-sterilized ophthalmic surgical instruments and cataract surgical products that were reused in multiple patients. This microbiological data complements clinical endophthalmitis data from 2 million consecutive cases at the Aravind Eye Hospital, suggesting that their instrument and surgical supply processing practices may allow for safe and sustainable ophthalmic care.