Erik Navas-Villar, Javier Jáuregui-Aguirre, Diego Melo-Orta, Ivonne Curiel-Arce, Salomon Merikansky, Erick Navarro, Arturo Chayet
{"title":"Simultaneous Pterygium and Cataract Removal with Light Adjustable Lens Implantation.","authors":"Erik Navas-Villar, Javier Jáuregui-Aguirre, Diego Melo-Orta, Ivonne Curiel-Arce, Salomon Merikansky, Erick Navarro, Arturo Chayet","doi":"10.1097/j.jcrs.0000000000001744","DOIUrl":"10.1097/j.jcrs.0000000000001744","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to report the refractive and visual outcomes of pseudophakic eyes that underwent simultaneous pterygium and cataract surgery with Light Adjustable Lens (LAL) implantation. This combined approach serves as an alternative to the traditional two-stage surgery, addressing logistical and financial concerns for patients requiring both procedures.</p><p><strong>Methods: </strong>This retrospective analysis included pseudophakic eyes that received simultaneous pterygium removal, cataract extraction, and LAL implantation between May 2021 and August 2024. Surgical procedures encompassed precise LAL calculations, pterygium excision, and cataract removal followed by LAL placement. Postoperative care included medications and custom LAL adjustments using the Light Delivery Device (LDD) to fine-tune refractive outcomes. Visual acuity, manifest refraction, and corneal astigmatism were recorded preoperatively, postoperatively before the first LAL adjustment, and again three months after surgery.</p><p><strong>Results: </strong>The study included 18 eyes from 14 patients. Three months post-surgery, refractive outcomes improved significantly, with a mean spherical equivalent (SEQ) of -0.29 D (±0.29). Half of the eyes achieved an SEQ of less than 0.25 D, and 83% achieved less than 0.5 D. Mean uncorrected distance visual acuity (UCDVA) improved to LogMAR 0.096 (±0.11). Refractive astigmatism also decreased notably, underscoring the effectiveness of the simultaneous procedure with LAL in attaining favorable visual outcomes.</p><p><strong>Conclusions: </strong>Simultaneous pterygium and cataract surgery with LAL implantation provides excellent refractive and visual outcomes, offering a viable alternative to staged surgery. Postoperative LAL adjustments help counteract corneal unpredictability associated with pterygium, making it a feasible choice for patients with financial or logistical challenges. Further research with larger sample sizes and extended follow-up periods is suggested to confirm these results.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144784317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Piotr Kanclerz, Natasza Bazylczyk, Idan Hecht, Raimo Tuuminen
{"title":"Surgical options for correcting refractive surprise following lens and cataract surgery: a review and meta-analysis.","authors":"Piotr Kanclerz, Natasza Bazylczyk, Idan Hecht, Raimo Tuuminen","doi":"10.1097/j.jcrs.0000000000001750","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001750","url":null,"abstract":"<p><strong>Topic: </strong>To compare the outcomes of surgical approaches to correct ametropia following cataract and lens surgery.</p><p><strong>Clinical relevance: </strong>Despite advancements in the field of biometry and intraocular lens (IOL) power calculation formulas, complete elimination of refractive surprises following cataract and lens surgery is impossible. Preferred Practice Patterns acknowledges the possibility of refractive surprise following cataract surgery; however, no recommendations regarding the preferred treatment have been given.</p><p><strong>Method: </strong>PubMed and Scopus were used to search the literature as of Nov 14, 2024. For the statistical analysis, the surgical options were divided into: (i) corneal refractive surgery and (ii) 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 best-corrected visual acuity (BCVA) expressed as LogMAR.</p><p><strong>Results: </strong>The postoperative SE was significantly better in eyes following 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<0.0001). Furthermore, the postoperative UDVA was better following 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<0.0001). Similarly, the postoperative BCVA was better following 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<0.0001).</p><p><strong>Conclusion: </strong>Corneal refractive surgery resulted in superior SE, UDVA and BCVA, and should be considered the primary approach for treating refractive surprise after cataract and lens surgery.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145033330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexandra Serfözö, Cristina Martin, Cristian Munteanu, Berthold Seitz, Loay Daas
{"title":"The efficacy, safety and predictability of transepithelial versus mechanical or alcohol-assisted photorefractive keratectomy - a meta-analysis.","authors":"Alexandra Serfözö, Cristina Martin, Cristian Munteanu, Berthold Seitz, Loay Daas","doi":"10.1097/j.jcrs.0000000000001749","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001749","url":null,"abstract":"<p><strong>Topic: </strong>The aim of this study was to assess the meta-analysis of the studies comparing transepithelial photorefractive keratectomy (TransPRK) to classical photorefractive keratectomy (PRK) (mechanical or alcohol-assisted).</p><p><strong>Clinical relevance: </strong>While PRK is a well-established procedure, TransPRK, a newer, minimally invasive technique may reduce surgery time and improve patient outcomes. Comparing these techniques helps optimize surgical choices.</p><p><strong>Methods: </strong>Relevant studies were collected from PubMed® and were included if they met the following criteria: comparison of TransPRK and PRK in terms of efficacy, safety, predictability, correction index, difference vector or index of success. The odds ratio (OR) estimates, risk ratio (RR) and 95% confidence intervals (CI) were derived from random-effects meta-analysis.</p><p><strong>Results: </strong>20 studies with a total of 10,204 treated eyes were included in this meta-analysis. The pooled estimates between TransPRK and PRK were as follows: log(OR) of the efficacy had a value of 0 CI=-0.32-0.33, log(OR) of the safety was 0.04 CI=-0.98-1.06 and log(OR) of the predictability was 0.48 CI=0.16-0.81.</p><p><strong>Conclusion: </strong>This meta-analysis showed that there were no statistically significant differences in either visual outcomes (efficacy, efficacy index, safety, safety index, predictability). Although TransPRK is preferred for its minimally invasive approach and quicker recovery, PRK continues to be a reliable option, particularly in environments where advanced technology is not easily affordable. The choice of laser platform can also influence the surgical outcomes through features like advanced pulse technology, optimized ablation speed and profiles.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145033353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Qi Wan, Rui Gong, Ran Wei, Jing Tang, Ying-Ping Deng, Ke Ma
{"title":"Multimodal Deep Learning for Predicting Postoperative Vault and Selecting ICL Sizes Using AS-OCT and UBM Images.","authors":"Qi Wan, Rui Gong, Ran Wei, Jing Tang, Ying-Ping Deng, Ke Ma","doi":"10.1097/j.jcrs.0000000000001747","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001747","url":null,"abstract":"<p><strong>Purpose: </strong>To develop and validate a multimodal deep-learning model for predicting postoperative vault height and selecting implantable collamer lens (ICL) sizes using Anterior Segment Optical Coherence Tomography (AS-OCT) and Ultrasound Biomicroscope (UBM) images combined with clinical features.</p><p><strong>Setting: </strong>West China Hospital of Sichuan University, China.</p><p><strong>Design: </strong>Deep-learning study.</p><p><strong>Methods: </strong>A total of 626 AS-OCT and 1309 UBM images from 209 eyes of 105 subjects with ICL V4c implantation were used. Features were extracted using a convolutional neural network (ResNet50) and combined with clinical data for model training. Machine learning algorithms including LightGBM, XGBoost, and Random Forest (RF) were employed to develop models for postoperative vault height prediction and ICL size selection. Models were validated using metrics such as Mean Absolute Error (MAE), Root Mean Squared Error (RMSE), R2, Accuracy, Sensitivity, Specificity, and Precision.</p><p><strong>Results: </strong>The LightGBM, XGBoost, and RF models showed RMSE values below 150 µm, MAE values below 120 µm, and R2 values around 0.4 in predicting postoperative vault height. The LightGBM model achieved the best performance in ICL size selection, with an accuracy of 0.904, sensitivity of 0.935, specificity of 0.907, and precision of 0.873, outperforming traditional methods and nearing the performance of senior doctors.</p><p><strong>Conclusions: </strong>The multimodal deep-learning model significantly improved the accuracy of predicting postoperative vault height and selecting ICL sizes for ICL V4c implantation, overcoming the limitations of single-modal data analysis. Future studies should expand sample sizes and conduct multicenter validations to enhance model generalizability and clinical applicability.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145033344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bruno Barbosa Ribeiro, Ana Sofia Martins, Luísa Malheiro, João Coelho, Miguel Mesquita Neves, Miguel Gomes, Luís Oliveira
{"title":"LONG TERM EFFICACY AND SAFETY OF IRIS-CLAW PHAKIC INTRAOCULAR LENS IN THE MANAGEMENT OF POST KERATOPLASTY ASTIGMATISM.","authors":"Bruno Barbosa Ribeiro, Ana Sofia Martins, Luísa Malheiro, João Coelho, Miguel Mesquita Neves, Miguel Gomes, Luís Oliveira","doi":"10.1097/j.jcrs.0000000000001748","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001748","url":null,"abstract":"<p><strong>Purpose: </strong>To demonstrate the efficacy and safety of iris-claw phakic intraocular lens (pIOL) in the treatment of post keratoplasty astigmatism.</p><p><strong>Setting: </strong>Cornea Unit, Ophthalmology Department - Unidade Local de Saúde de Santo António - Porto, Portugal.</p><p><strong>Design: </strong>Retrospective longitudinal study.</p><p><strong>Methods: </strong>Analysis of patients submitted to iris-claw phakic IOL implantation after previous Penetrating Keratoplasty (PK) or Deep Anterior Lamellar Keratoplasty (DALK) between January 2013 and December 2023. Patients submitted to other refractive procedures and without minimum 1-year follow-up were excluded. Demographic data, spherical equivalent (SE), uncorrected (UDVA) and corrected (CDVA) distance visual acuity was registered preoperatively, at the intermediate visit (12-18 months), 5 years, and 10 years postoperatively. Vector analysis to plot corneal Surgically Induced Astigmatism was performed. Endothelial cell density (ECD) was evaluated at each visit using the same specular microscope.</p><p><strong>Results: </strong>We enrolled 39 eyes of 29 patients submitted to Keratoplasty due to Keratoconus (71.8% [n=28] DALK). At the intermediate visit, 19 eyes (49%) had a postoperative UDVA ≥ 20/32, and 6 (15%) had ≥ 20/20. Efficacy index was 0.83. 16 (11%) achieved full refractive correction without loss of CDVA, and 9 (23%) gained ≥ 1 lines of vision. 28 (72%) eyes were within ±1.00 D of plano refraction. Globally, 25 (64%) eyes showed a residual astigmatism ≤1.00 D. Average annual ECD loss was 3.07% for DALK and 9.34% for PK (p=0.006).</p><p><strong>Conclusions: </strong>Iris-claw pIOL is effective for treating post keratoplasty astigmatism. Given the risk of progressive endothelial cell loss, strict follow-up is mandatory, especially after PK.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145033410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Posterior synechiae and cataract formation as a late complication of a foldable iris-fixated phakic IOL.","authors":"Titus Schug, Petra Dávidová, Thomas Kohnen","doi":"10.1097/j.jcrs.0000000000001746","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001746","url":null,"abstract":"","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144690396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Visual Performance of a Novel Wavefront Shaping Extended Depth-of-Focus Intraocular Lens on a New Hydrophobic Acrylic Platform.","authors":"John P Berdahl, Leslie Grosinger, Olivia Reed","doi":"10.1097/j.jcrs.0000000000001742","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001742","url":null,"abstract":"<p><strong>Purpose: </strong>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).</p><p><strong>Setting: </strong>8 investigational sites in the U.S.</p><p><strong>Design: </strong>Ambispective, non-randomized, controlled clinical study.</p><p><strong>Methods: </strong>Participants aged ≥ 18 years bilaterally implanted with either Clareon EDOF IOLs (Clareon EDOF) or Clareon Monofocal IOLs 3-6 months prior to enrollment were included. Two 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.</p><p><strong>Results: </strong>The study included 149 participants (n=73 Clareon EDOF, n=75 Clareon Monofocal). Clareon EDOF was non-inferior to the Monofocal for binocular CDVA (MD: 0.034, 95% CI: 0.001, 0.067). Clareon EDOF was superior to the Monofocal for binocular DCIVA (MD: -0.091, 95% CI: -0.120, -0.061) and for binocular DCNVA (MD: -0.129, 95% CI: -0.169, -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.</p><p><strong>Conclusions: </strong>This study supports the continued performance of the EDOF design on the Clareon platform by demonstrating comparable distance vision and a visual disturbance profile to a monofocal control, and superior intermediate vision, near vision, and spectacle independence.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Veronika Yehezkeli, Eran Greenbaum, Avner Belkin, Ehud I Assia, Ornit Crystal-Shalit, Noa Ela-Dalman
{"title":"Anchor-Assisted Capsular Bag IOL Implantation to Correct Subluxated Lenses in Children with Marfan Syndrome: Long Term Follow-Up.","authors":"Veronika Yehezkeli, Eran Greenbaum, Avner Belkin, Ehud I Assia, Ornit Crystal-Shalit, Noa Ela-Dalman","doi":"10.1097/j.jcrs.0000000000001741","DOIUrl":"10.1097/j.jcrs.0000000000001741","url":null,"abstract":"<p><strong>Purpose: </strong>Crystalline lens subluxation in children with Marfan syndrome often requires surgical correction to prevent amblyopia. Capsular anchor device (AssiAnchor, Hanita Lenses, Israel) enables the preservation of the capsular bag for the placement of a Posterior Chamber Intraocular Lens, maintaining natural anatomy and effective lens position.</p><p><strong>Setting: </strong>Department of Ophthalmology, Meir Medical Center, Kfar Saba, Israel.</p><p><strong>Design: </strong>Retrospective, consecutive case series.</p><p><strong>Methods: </strong>We collected data on pediatric patients with genetically or clinically confirmed Marfan syndrome who underwent lens extraction with IOL implantation and bag preservation using the AssiAnchor device.</p><p><strong>Results: </strong>A total of 10 eyes of 8 patients were included. Mean postoperative follow-up was 5.08 years (range 2-9.25 years). Average age at surgery was 6.9±3.3 years (range 2.8-13.75). The mean best-corrected visual acuity improved from 20/80 to 20/30 (p=0.01). Mean Absolute Error from the aimed refraction was -0.37±0.6 D (range -1.25 to 0.75 D). At the last follow-up, all IOLs were stable and central, with healthy conjunctival tissue over the sutures and flanges. Postoperative complications included glaucoma in 1 eye and IOL subluxation in 2 eyes of the same patient. Posterior capsular opacification occurred in 6 eyes, strabismus developed in one patient and resolved in two patients. Amblyopia was identified in 6 eyes (60%), comprising 5 mild cases and 1 moderate case.</p><p><strong>Conclusions: </strong>The capsular anchor device effectively managed lens subluxation in pediatric Marfan syndrome, providing long-term stabilization of the capsular bag and facilitated IOL implantation. Our findings demonstrate satisfactory visual and refractive outcomes with an acceptable rate of complications.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144784314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthew T Hirabayashi, Gurpal S Virdi, Taj A Nasser, Andrew Abramson, Gregory D Parkhurst
{"title":"VAULT-OCT: Vault Accuracy Using Deep Learning Technology - An AI Model for Predicting Implantable Collamer Lens Postoperative Vault with AS-OCT.","authors":"Matthew T Hirabayashi, Gurpal S Virdi, Taj A Nasser, Andrew Abramson, Gregory D Parkhurst","doi":"10.1097/j.jcrs.0000000000001743","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001743","url":null,"abstract":"<p><strong>Purpose: </strong>To develop an accurate deep learning model, VAULT-OCT, to predict postoperative vault of phakic Implantable Collamer Lenses (ICLs) based on pre-operative OCT.</p><p><strong>Setting: </strong>Parkhurst NuVision LASIK Eye Surgery, San Antonio, Texas, USA.</p><p><strong>Design: </strong>Retrospective Machine Learning Study.</p><p><strong>Methods: </strong>A total of 324 eyes from 162 consecutive patients who underwent ICL implantation were included. VAULT-OCT, the neural network, was trained on pre-operative anterior segment (AS) optical coherence tomography (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 (RMSE) on the test set, with Mean Absolute Error (MAE) reported as the primary performance metric.</p><p><strong>Results: </strong>A mean absolute error (MAE) of 22.3 µm, 21.7 µm, and 98.1 µm and a standard deviation 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.</p><p><strong>Conclusions: </strong>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 pre-operative AS-OCT.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ayesh Ali, Philip W Dockery, David G Downes, Deborah K VanderVeen, Abdelrahman M Elhusseiny
{"title":"Primary Suspect Drugs of Cataracts in Pediatric Patients: An FDA Adverse Events Reporting Database Analysis.","authors":"Ayesh Ali, Philip W Dockery, David G Downes, Deborah K VanderVeen, Abdelrahman M Elhusseiny","doi":"10.1097/j.jcrs.0000000000001738","DOIUrl":"https://doi.org/10.1097/j.jcrs.0000000000001738","url":null,"abstract":"<p><strong>Purpose: </strong>To identify primary suspect drugs potentially associated with pediatric cataracts by analyzing reports from the Food and Drug Administration Adverse Event Reporting System (FAERS).</p><p><strong>Setting: </strong>Database study.</p><p><strong>Design: </strong>Retrospective observational pharmacovigilance study.</p><p><strong>Methods: </strong>FAERS reports submitted between 2004 and 2024 involving patients ≤18 years 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 five established data mining algorithms: proportional reporting ratio (PRR), chi-squared with Yates' correction (χ2), reporting odds ratio (ROR), empirical Bayes geometric mean (EBGM), and information component (IC). Positive signals were defined using threshold criteria established in pharmacovigilance literature.</p><p><strong>Results: </strong>The mean patient age was 9.39 ± 4.59 years. Ninety-one 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, χ2=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, χ2=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, χ2=204.17, ROR 95% CI: 9.89 [6.76-14.46], EBGM [EBGM05]: 3.39 [2.36], IC [IC05]: 3.01 [2.45]).</p><p><strong>Conclusion: </strong>Three 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.</p>","PeriodicalId":15214,"journal":{"name":"Journal of cataract and refractive surgery","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144608495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}