Journal of cataract and refractive surgery最新文献

Purpose: To evaluate the real-world performance and safety of a nondiffractive, wavefront shaping, extended depth-of-focus (EDOF) intraocular lens (IOL) on the new hydrophobic acrylic Clareon platform (Clareon Vivity/Vivity Toric) compared with a monofocal control (Clareon Monofocal/Toric).

Setting: 8 investigational sites in the United States.

Design: Ambispective, nonrandomized, controlled clinical study.

Methods: Participants aged 18 years or older bilaterally implanted with either Clareon EDOF IOLs (Clareon EDOF) or Clareon Monofocal IOLs 3 to 6 months before enrollment were included. 2 prospective visits were conducted to collect performance data and a retrospective chart review to collect baseline and safety data. Performance endpoints included binocular photopic corrected distance visual acuity (CDVA), distance-corrected intermediate visual acuity (DCIVA), distance-corrected near visual acuity (DCNVA), and rate of spectacle independence.

Results: The study included 149 participants (n = 73 Clareon EDOF, n = 75 Clareon Monofocal). Clareon EDOF was noninferior to the Monofocal for binocular CDVA (mean difference [MD] = 0.034, 95% CI 0.001 to 0.067). Clareon EDOF was superior to the Monofocal for binocular DCIVA (MD = -0.091, 95% CI -0.120 to -0.061) and for binocular DCNVA (MD = -0.129, 95% CI -0.169 to -0.089). Rates of "never/rarely" needing spectacles were 45.7% in the Clareon EDOF group and 16.4% in the Monofocal group. Rates of severe visual disturbances were ≤5.6% and ≤4% in the Clareon EDOF and Monofocal groups, respectively.

Conclusions: This study supports the continued performance of the EDOF design on the Clareon platform by demonstrating comparable distance vision and a visual disturbance profile with a monofocal control, and superior intermediate vision, near vision, and spectacle independence.

Purpose: To identify primary suspect drugs potentially associated with pediatric cataracts by analyzing reports from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Setting: Database study.

Design: Retrospective observational pharmacovigilance study.

Methods: FAERS reports submitted between 2004 and 2024 involving patients aged 18 years or younger with adverse events listed as cataract and its subtypes. Descriptive statistics summarized patient demographics and drug reporting frequencies. A signal detection analysis was conducted using 5 established data mining algorithms: proportional reporting ratio (PRR), chi-squared with Yates' correction (χ 2 ), reporting odds ratio (ROR), empirical Bayes geometric mean (EBGM), and information component (IC). Positive signals were defined using threshold criteria established in pharmacovigilance literature.

Results: The mean patient age was 9.39 ± 4.59 years. 91 drugs were listed as primary suspect drugs. The most frequently reported drugs were ivacaftor and prednisolone (n = 29, 7%), followed by methotrexate and adalimumab (n = 26, 6%). Topotecan demonstrated the strongest positive signal (n = 12, PRR = 47.34, χ 2 = 477.86, ROR 95% CI: 48.84 [27.15-87.86], EBGM [EBGM05]: 18.13 [9.8], IC [IC05]: 4.03 [3.11]), followed by ivacaftor (n = 29, PRR = 12.04, χ 2 = 281.28, ROR 95% CI: 12.95 [8.85-18.94], EBGM [EBGM05]: 5.46 [3.78], IC [IC05]: 3.33 [2.77]), and prednisolone (n = 29, PRR = 9.22, χ 2 = 204.17, ROR 95% CI: 9.89 [6.76-14.46], EBGM [EBGM05]: 3.39 [2.36], IC [IC05]: 3.01 [2.45]).

Conclusions: 3 potential drug-adverse event pairs were identified for pediatric cataracts, including a previously infrequently described association with ivacaftor and topotecan. Prednisolone, consistent with known corticosteroid-induced cataractogenesis, also demonstrated a positive signal. These findings raise drug safety concerns and warrant further investigation.

Purpose: To develop an accurate deep learning model, VAULT-OCT, to predict postoperative vault of phakic implantable collamer lenses (ICLs) based on preoperative optical coherence tomography (OCT).

Setting: Parkhurst NuVision LASIK Eye Surgery, San Antonio, Texas.

Design: Retrospective machine learning study.

Methods: 324 eyes from 162 consecutive patients who underwent ICL implantation were included. VAULT-OCT, the neural network, was trained on preoperative anterior segment OCT (AS-OCT) images paired with postoperative vault measurements for different ICL sizes. Incomplete data were excluded, and the images were consistently resized and normalized. A custom classifier was used in VAULT-OCT, and model performance was evaluated using root mean squared error on the test set, with mean absolute error (MAE) reported as the primary performance metric.

Results: A MAE of 22.3 μm, 21.7 μm, and 98.1 μm and a SD of 13.5 μm, 17.8 μm, and 105.9 μm were achieved with 100%, 100%, and 89.1% of predictions within 200 μm, for the 12.1 mm, 12.6 mm, and 13.2 mm size, respectively.

Conclusions: This OCT-based deep learning model, VAULT-OCT, achieved a high level of accuracy in predicting postoperative ICL vault, with most predictions falling within a clinically acceptable margin of vault, suggesting the feasibility of basing ICL sizing on preoperative AS-OCT.

Purpose: To address the calculation of intraocular lens (IOL) power in myopic eyes undergoing simultaneous anterior or posterior chamber phakic IOL (pIOL) explantation and lens extraction surgery, a procedure known as bilensectomy, in comparison with myopic eyes without pIOL (controls).

Design: Retrospective analysis of comparability and accuracy.

Setting: Department of Ophthalmology, Goethe-University, Frankfurt, Germany.

Methods: IOLMaster 700 and Pentacam AXL were used for biometry. IOL power was calculated using the Barrett Universal II (BUII), Cooke K6, Hoffer-QST, Emmetropia Verifying Optical Formula v2.0 (EVO 2.0), Prediction Enhanced by Artificial Intelligence and output Linearization-Debellemaniere, Gatinel, and Saad (PEARL-DGS), Hill-Radial Basis Function (Hill-RBF), and Kane formulas included in the ESCRS online calculator, as well as the T2 and Ladas super formula and the SRK/T and Holladay 1 with or without Wang-Koch axial length (AL) adjustment.

Results: 60 eyes (mean AL: 29.1 ± 2.06 mm) of 60 patients (mean age 57.4 ± 10.9 years) were included. 30 eyes underwent bilensectomy, and 30 served as controls. In bilensectomy eyes, Kane (0.53 diopter [D]), PEARL-DGS (0.56 D), and Hill-RBF (0.61 D) demonstrated the lowest root-mean square of the absolute error. PEARL-DGS demonstrated the highest percentage of eyes within ±0.25 D (46.7%), followed by BUII, Hill-RBF, and Kane (40.0%, each). EVO 2.0 showed a significant difference ( P = .001) in mean prediction error between the bilensectomy group and the control group. All other formulas showed no significant differences between the 2 groups (each P > .05).

Conclusions: Simultaneous explantation of a pIOL does not seem to exert a considerable impact on the IOL power calculation in myopic eyes. The performance of the formulas is comparable with myopic eyes without pIOLs.

Topic: To compare the outcomes of surgical approaches to correct ametropia after cataract and lens surgery.

Clinical relevance: Despite advancements in the field of biometry and intraocular lens (IOL) power calculation formulas, complete elimination of refractive surprises after cataract and lens surgery is impossible. Preferred Practice Patterns acknowledges the possibility of refractive surprise after cataract surgery; however, no recommendations regarding the preferred treatment have been given.

Methods: PubMed and Scopus were used to search the literature as of November 14, 2024. For the statistical analysis, the surgical options were divided into (1) corneal refractive surgery and (2) supplementary IOL implantation. Studies regarding IOL exchange have been mentioned; however, due to the insufficient total number of eyes, they were not included in the meta-analysis. Outcomes included postoperative spherical equivalent (SE) in diopters, uncorrected distance visual acuity (UDVA), and corrected distance visual acuity (CDVA) expressed as logMAR.

Results: The postoperative SE was significantly better in eyes after corneal refractive surgery (0.02; 95% CI -0.06 to 0.10) than after supplementary IOL implantation (-0.21; 95% CI -0.77 to 0.36; P < .0001). Furthermore, the postoperative UDVA was better after corneal refractive surgery (0.04; 95% CI -0.03 to 0.10), than after supplementary IOL implantation (0.12; 95% CI -0.03 to 0.28; P < .0001). Similarly, the postoperative CDVA was better after corneal refractive surgery (-0.01; 95% CI -0.06 to 0.04) than after supplementary IOL implantation (0.06; 95% CI -0.07 to 0.18; P < .0001).

Conclusions: Corneal refractive surgery resulted in superior SE, UDVA, and CDVA, and should be considered the primary approach for treating refractive surprise after cataract and lens surgery.