Thanadet Chuangsuwanich, Monisha E Nongpiur, Fabian A Braeu, Tin A Tun, Alexandre Thiery, Shamira Perera, Ching Lin Ho, Martin Buist, George Barbastathis, Tin Aung, Michaël J A Girard
{"title":"Biomechanics-Function in Glaucoma: Improved Visual Field Predictions from IOP-Induced Neural Strains.","authors":"Thanadet Chuangsuwanich, Monisha E Nongpiur, Fabian A Braeu, Tin A Tun, Alexandre Thiery, Shamira Perera, Ching Lin Ho, Martin Buist, George Barbastathis, Tin Aung, Michaël J A Girard","doi":"10.1016/j.ajo.2024.11.019","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.019","url":null,"abstract":"<p><strong>Purpose: </strong>(1) To assess whether neural tissue structure and biomechanics could predict functional loss in glaucoma; (2) To evaluate the importance of biomechanics in making such predictions.</p><p><strong>Design: </strong>Clinic-based cross-sectional study.</p><p><strong>Methods: </strong>We recruited 238 glaucoma subjects (Chinese ethnicity, more than 50 years old). For one eye of each subject, we imaged the optic nerve head (ONH) using spectral-domain OCT under the following conditions: (1) primary gaze and (2) primary gaze with acute IOP elevation (to approximately 35 mmHg) achieved through ophthalmo-dynamometry. We utilized automatic segmentation of optic nerve head (ONH) tissues and digital volume correlation (DVC) analysis to compute intraocular pressure (IOP)-induced neural tissue strains. A robust geometric deep learning approach, known as Point-Net, was employed to predict the full Humphrey 24-2 pattern standard deviation (PSD) maps from ONH structural and biomechanical information. For each point in each PSD map, we predicted whether it exhibited no defect or a PSD value of less than 5%. Predictive performance was evaluated using 5-fold cross-validation and the F1-score. We compared the model's performance with and without the inclusion of IOP-induced strains to assess the impact of biomechanics on prediction accuracy.</p><p><strong>Results: </strong>Integrating biomechanical (IOP-induced neural tissue strains) and structural (tissue morphology and neural tissues thickness) information yielded a significantly better predictive model (F1-score: 0.76 ± 0.02) across validation subjects, as opposed to relying only on structural information, which resulted in a significantly lower F1-score of 0.71 ± 0.02 (p < 0.05). Our subjects had a mean age of 69±5 years. Among them, 88 were female. The cohort included a wide range of glaucoma severity, with Mean Deviation (MD) values ranging from -1.8 (mild) to -25.2 (severe), and an average MD value of -7.25±5.05.</p><p><strong>Conclusion: </strong>Our study has shown that the integration of biomechanical data can significantly improve the accuracy of visual field loss predictions and highlights the importance of the biomechanics-function relationship in glaucoma.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Asahi Fujita, Daniel M Vu, Kanza Aziz, Ta Chen Chang, In Young Chung, Elizabeth C Ciociola, David S Friedman, Anagha Lokhande, Alice C Lorch, Joan W Miller, Prashit Parikh, Adam L Rothman, Kasem Seresirikachorn, Tobias Elze, Nazlee Zebardast, Suzann Pershing, Leslie Hyman, Julia A Haller, Aaron Y Lee, Cecilia S Lee, Flora Lum, Joan W Miller, Alice Lorch
{"title":"Treatment patterns of childhood glaucoma in the United States: Analysis of IRIS® Registry (Intelligent Research in Sight).","authors":"Asahi Fujita, Daniel M Vu, Kanza Aziz, Ta Chen Chang, In Young Chung, Elizabeth C Ciociola, David S Friedman, Anagha Lokhande, Alice C Lorch, Joan W Miller, Prashit Parikh, Adam L Rothman, Kasem Seresirikachorn, Tobias Elze, Nazlee Zebardast, Suzann Pershing, Leslie Hyman, Julia A Haller, Aaron Y Lee, Cecilia S Lee, Flora Lum, Joan W Miller, Alice Lorch","doi":"10.1016/j.ajo.2024.11.020","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.020","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate treatment patterns of childhood glaucoma in the United States.</p><p><strong>Design: </strong>Retrospective clinical cohort study SUBJECTS: Patients under 18 years of age with a diagnosis code for glaucoma between January 1, 2013, and December 31, 2020, in the IRIS® Registry (Intelligent Research in Sight).</p><p><strong>Methods: </strong>Patient demographic information and clinical characteristics were extracted. A Cox regression model was used to determine predictors of undergoing incisional glaucoma surgery.</p><p><strong>Main outcome measures: </strong>The primary outcomes were the percentage of childhood glaucoma eyes that underwent glaucoma-related procedures and those receiving intraocular pressure (IOP)-lowering medications. Our secondary outcomes were hazard ratios (HRs) of demographic and clinical factors for undergoing incisional surgeries.</p><p><strong>Results: </strong>A total of 5017 eyes of 3069 patients were included in this study. Based on billing codes, 208 eyes (4.1%) had primary congenital glaucoma (PCG), 1911 eyes (38.1%) had juvenile open-angle glaucoma (JOAG), 999 eyes (19.9%) had glaucoma following cataract surgery (GFCS), and 1646 (32.8%) had secondary glaucoma other than GFCS. Out of 5017 eyes with childhood glaucoma, 808 eyes (16.1%) underwent glaucoma-related procedures, and 4698 eyes (93.6%) received antiglaucoma medications. Angle surgery was the most common first-recorded procedure for PCG, and tube shunt surgery for GFCS and secondary glaucoma. Laser trabeculoplasty was mainly performed for JOAG by non-glaucoma subspecialists. Factors associated with higher likelihood of incisional surgeries were PCG (vs. JOAG, HR 5.40, 95% confidence interval [CI] 1.55-18.84, p = 0.008), increase in IOP (HR 1.06 per mmHg, CI 1.05-1.08, p<0.001), and index date at age < one year (vs. ages 11-15 years, HR 6.08, CI 1.51 - 24.44, p = 0.011). Being cared for by a non-glaucoma subspecialist was associated with a lower likelihood of undergoing incisional surgery (HR: 0.32 (95%CI: 0.23 - 0.44, p<0.001).</p><p><strong>Conclusions: </strong>We found that 1 in 6 childhood glaucoma eyes underwent glaucoma-related procedures, and nearly all received antiglaucoma medications. The choice of first-recorded procedure differed across age and diagnosis. Type of glaucoma, baseline IOP, age, and type of treating subspecialist were predictors for undergoing incisional glaucoma surgery.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rohith Erukulla, Mohammad Soleimani, Maria Woodward, Niranjan Karnik, Charlotte Joslin, Timothy McMahon, Angelica Scanzera, Ellen Shorter, Hannah Yoon, Maria Cortina, Jose de la Cruz, Sandeep Jain, Hajirah Saeed, Elmer Tu, Mark Rosenblatt, Ali Djalilian
{"title":"Socioeconomic and Demographic Disparities in Keratoconus Treatment.","authors":"Rohith Erukulla, Mohammad Soleimani, Maria Woodward, Niranjan Karnik, Charlotte Joslin, Timothy McMahon, Angelica Scanzera, Ellen Shorter, Hannah Yoon, Maria Cortina, Jose de la Cruz, Sandeep Jain, Hajirah Saeed, Elmer Tu, Mark Rosenblatt, Ali Djalilian","doi":"10.1016/j.ajo.2024.11.023","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.023","url":null,"abstract":"<p><strong>Objective: </strong>To investigate healthcare disparities associated with keratoconus (KCN) patients receiving treatment (collagen cross-linking (CXL) and keratoplasty), as well as comorbidities associated with KCN.</p><p><strong>Design: </strong>Retrospective clinical cohort study.</p><p><strong>Subjects: </strong>3224 patients from the UI-Health database from 2020 to 2024, including 1612 patients with an ICD-10 diagnosis of KCN and 1612 ophthalmology patients as a control group.</p><p><strong>Methods: </strong>Multivariable and univariable logistic regression were performed to evaluate association between sociodemographic traits and rates of CXL and keratoplasty. Sociodemographic traits included age, sex, race/ethnicity, insurance status, and neighborhood social vulnerability. Best corrected visual acuity (BCVA) and manifest cylinder were used as indicators of disease impact. Comorbid disease rates were compared to a 1:1 distance-matched control group.</p><p><strong>Main outcome measures: </strong>Odds ratio of undergoing keratoplasty and CXL, and prevalence of comorbid conditions.</p><p><strong>Results: </strong>Females received less keratoplasty than males (OR=0.55, P<0.001). Black individuals received less CXL than White individuals (OR=0.68, P<0.05), as did those with Medicaid (OR=0.27, P<0.0001) or no insurance (OR=0.41, P<0.001) compared to those with commercial insurance. Socially vulnerable neighborhoods received less CXL (OR=0.56, P<0.01) and keratoplasty (OR=0.66, P<0.05). Black females were the most vulnerable, undergoing fewer procedures than White females (OR=0.58, P<0.01) and Black males (OR=0.65, P<0.05). Black and Hispanic/Latin-X individuals presented with more severe disease (P<0.01, P<0.0001). Down Syndrome was more common (P<0.01), and diabetes was less common (P<0.0001) in KCN patients.</p><p><strong>Conclusions: </strong>Significant sociodemographic disparities exist in the treatment of KCN. While further research is necessary, addressing these disparities is crucial for ensuring equitable access to care.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Malena Daich Varela, Memuna Rashid, Andre Lopes, Michel Michaelides
{"title":"The effects of pregnancy on disease progression of retinitis pigmentosa.","authors":"Malena Daich Varela, Memuna Rashid, Andre Lopes, Michel Michaelides","doi":"10.1016/j.ajo.2024.11.016","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.016","url":null,"abstract":"<p><strong>Purpose: </strong>Retinitis pigmentosa (RP) is the most common diagnosis in the ophthalmic genetics' clinic. Women with RP are often diagnosed during their reproductive years, posing significant challenges for family planning. The effects of pregnancy on RP progression is a frequently unanswered concern for these patients.</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Subjects: </strong>Women who attended Moorfields Eye Hospital (London, UK) and met the following inclusion criteria were included in this study: (i) had their most recent visit at 30 years old or more, (ii) were diagnosed with RP, (iii) had information in their medical records about having had children, and (iv) were found to have biallelic rare or likely disease-causing variants in USH2A.</p><p><strong>Methods: </strong>The cohort was divided into parous and nulliparous, and multivariate Cox regressions adjusting for multiple confounding effects was performed. A further analysis also included number of children as a variable.</p><p><strong>Main outcome measures: </strong>RP severity criteria based on visual acuity (VA) and ellipsoid zone (EZ) width, and national registration of sight impairment.</p><p><strong>Results: </strong>142 women were included in the study, 98 parous (69%) and 44 nulliparous (31%). In the parous group, 21% had cystoid macular oedema (CMO) requiring treatment and 46% had cataracts or were pseudophakic, versus 18% with CMO and 59% with cataracts in the nulliparous. Women had a median of 2 children. A significant association was only found in parous women having 3.04 (1.23-7.48) times increased risk of having VA worse than LogMAR 0.7 than nulliparous (p= 0.016), after adjusting for baseline age, phenotype, cataract status, and CMO.</p><p><strong>Conclusions: </strong>This is the first large-scale objective study analysing the effects of pregnancy in genetically-confirmed women with RP. Women with USH2A-associated RP who had children appeared to have 3.04 times the risk of reaching VA below 6/24 than those who did not have children. It is possible that other factors besides retinal degeneration are affecting central vision and causing this increased risk. A significant association between faster or slower EZ loss and pregnancy was not present in our cohort. We believe these findings will be relevant to all women with RP considering starting a family; although further studies are needed.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexander A Dennis, David S Portney, Hakan Demirci
{"title":"Surgical Costs of Enucleation vs. Plaque Brachytherapy for Intraocular Malignancy: A Time-Driven Activity-Based Costing Approach.","authors":"Alexander A Dennis, David S Portney, Hakan Demirci","doi":"10.1016/j.ajo.2024.11.018","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.018","url":null,"abstract":"<p><strong>Objective: </strong>To compare costs between enucleation and plaque brachytherapy procedures for the treatment of intraocular malignancies.</p><p><strong>Design: </strong>Retrospective economic analysis using a time-driven activity-based costing (TDABC) methodology.</p><p><strong>Subjects: </strong>Patients undergoing plaque brachytherapy and enucleation procedures for the treatment of intraocular malignancy performed at the University of Michigan Kellogg Eye Center from 2021-2022.</p><p><strong>Methods: </strong>Data inputs were obtained from the Electronic Health Record (EHR) and prior literature. Associated expenses were determined using TDABC, a method for cost calculation that correlates the cost rate of each resource used in a procedure with the amount of time that the resource is used.</p><p><strong>Main outcome measures: </strong>The primary outcome was the difference in total cost associated with enucleation versus plaque brachytherapy procedures. Secondary outcomes included length of surgery (in minutes), total day-of-surgery costs, and number of follow-up visits.</p><p><strong>Results: </strong>145 cases were included, with 41 enucleations and 104 courses of plaque brachytherapy.. Between all enucleation and plaque brachytherapy procedures, plaque brachytherapy was significantly more costly ($10,140.95 vs. $6,127.70, P < 0.01), with total difference in cost of $4013 (95% confidence interval $3352.02 to $4674.47). There was no significant difference in OR time between enucleation and plaque brachytherapy. Plaque brachytherapy required significantly more follow-up visits than enucleation (1.02 visits vs. 0.59 visits, P < 0.01).</p><p><strong>Conclusions: </strong>Through TDABC cost analysis, we determined that the surgical course of plaque brachytherapy is more costly than enucleation, with the primary cost drivers being cost of the radiotherapy plaque and radiation oncology-related expenses.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comment on \"Retinal and Choroidal Phenotypes Across Novel Subtypes of Type 2 Diabetes Mellitus\".","authors":"Kefan Mou, Ming Zhang","doi":"10.1016/j.ajo.2024.10.036","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.10.036","url":null,"abstract":"","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142764987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shady T Awwad, Bassel Hammoud, Jad F Assaf, Lara Asroui, James Bradley Randleman, Cynthia J Roberts, Douglas D Koch, Jawad Kaisania, Carl-Joe Mehanna, Shadi Elbassuoni
{"title":"Thickness Speed Progression Index: Machine Learning Approach for Keratoconus Detection.","authors":"Shady T Awwad, Bassel Hammoud, Jad F Assaf, Lara Asroui, James Bradley Randleman, Cynthia J Roberts, Douglas D Koch, Jawad Kaisania, Carl-Joe Mehanna, Shadi Elbassuoni","doi":"10.1016/j.ajo.2024.11.011","DOIUrl":"10.1016/j.ajo.2024.11.011","url":null,"abstract":"<p><strong>Purpose: </strong>To develop and validate a pachymetry-based machine learning (ML) index for differentiating keratoconus, keratoconus suspect, and normal corneas.</p><p><strong>Design: </strong>Development and validation of an ML diagnostic algorithm.</p><p><strong>Methods: </strong>This retrospective study included 349 eyes of 349 patients with normal, frank keratoconus (KC), and KC suspect (KCS) corneas. KCS corneas included topographically/tomographically normal (TNF) and borderline fellow eyes (TBF) of patients with asymmetric KC. Six parameters were derived from the corneal thickness progression map on the Galilei Dual Scheimpflug-Placido system and fed into a machine-learning algorithm to create the Thickness Speed Progression Index. The model was trained with 5-fold cross-validation using a random search over 7 different ML algorithms, and the best model and hyperparameters were selected.</p><p><strong>Results: </strong>A total of 133 normal eyes, 141 KC eyes, and 75 KCS eyes, subdivided into 34 TNF and 41 TBF eyes, were included. In experiment 1 (normal and KC), the best model (Random Forest) achieved an accuracy of 100% and area under the receiver operating characteristic (AUROC) of 1.00 for both normal and KC groups. In experiment 2 (normal, KCS, and KC), the model achieved an overall accuracy of 91%, and AUROC curves of 0.93, 0.83, and 0.99 in detecting normal, KCS, and KC corneas respectively. In experiment 3 (normal, TNF, TBF, and KC), the model achieved an accuracy of 87% with AUROC curves of 0.91, 0.60, 0.77, and 0.94 for normal, TNF, TBF, and KC corneas, respectively.</p><p><strong>Conclusions: </strong>Using data solely based on pachymetry, ML algorithms such as the Thickness Speed Progression Index are able to discriminate normal corneas from KC and KCSs corneas with reasonable accuracy.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":"188-201"},"PeriodicalIF":4.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ali A Alkhabbaz, Mohammad H Karam, André S Pollmann, Siddharth Nath, Tsz Hin Alexander Lau, Hamad Al-Awadhi, Khaldon Abbas, Samir Jabbour
{"title":"Safety and Efficacy of Posterior Chamber Phakic Implantable Collamer Lenses in Patients with Keratoconus: A Systematic Review and Meta-Analysis.","authors":"Ali A Alkhabbaz, Mohammad H Karam, André S Pollmann, Siddharth Nath, Tsz Hin Alexander Lau, Hamad Al-Awadhi, Khaldon Abbas, Samir Jabbour","doi":"10.1016/j.ajo.2024.11.013","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.013","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the safety and efficacy of phakic implantable collamer lenses (ICLs) in patients with keratoconus.</p><p><strong>Design: </strong>Systematic review and meta-analysis.</p><p><strong>Methods: </strong>We conducted a pre- and post-intervention single-arm systematic review and meta-analysis in line with guidelines from the Cochrane Collaboration and the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) 2020 Consensus Statement. We searched five electronic databases and the grey literature for any studies evaluating ICLs in the setting of keratoconus. Our primary outcomes were the corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), and manifest cylinder astigmatism. Secondary outcomes included uncorrected near visual acuity (UNVA), spherical equivalent, refractive astigmatism, higher-order aberrations (HOAs), endothelial cell density (ECD), intraocular pressure (IOP), and incidence of adverse events. We summarized our analyses by calculating standardized mean differences (SMDs) with associated 95% confidence intervals (CIs) using random-effects meta-analysis.</p><p><strong>Results: </strong>Sixteen observational studies, totalling 397 eyes, were eligible. Post-operatively, there was no statistically significant improvement in CDVA (SMD: -0.97, 95% CI: -1.99 to 0.05, p<0.06); there was a statistically significant improvement in UDVA (SMD: -5.41, 95% CI: -0.704 to -3.78, p<0.05), manifest cylinder (SMD: 2.27, 95% CI: 1.83 to 2.70, p<0.05), spherical equivalent (SMD:-4.66, 95% CI: -5.63 to 3.68, p<0.05), and refractive astigmatism (SMD: 2.22, 95% CI: 1.03 to 3.41, p<0.05). No significant adverse events occurred.</p><p><strong>Conclusions: </strong>Use of ICLs in patients with keratoconus is safe and effective, resulting in significant improvements in a myriad of visual and refractive measures. Our results remain limited by the observational design of included studies as well as the limited follow-up duration.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew J Clark, Carl Regillo, Shamika Gune, Dante J Pieramici
{"title":"Refillable Drug Reservoirs for Retinal Vascular Diseases.","authors":"Andrew J Clark, Carl Regillo, Shamika Gune, Dante J Pieramici","doi":"10.1016/j.ajo.2024.11.009","DOIUrl":"https://doi.org/10.1016/j.ajo.2024.11.009","url":null,"abstract":"<p><strong>Purpose: </strong>Most patients with retinal vascular disease require chronic, regular treatments to maximize visual potential. This places a challenging burden on the patient and is one reason why real-world visual outcomes often lag the results seen in clinical trials.</p><p><strong>Review: </strong>Sustained drug delivery devices have long been considered one way to alleviate this difficulty. In particular, devices with refillable reservoirs aim to take advantage of existing drugs to improve their pharmacokinetics and reduce treatment frequency. Very few devices utilizing a refillable reservoir have reached human clinical trials, however. Only one, the Port Delivery System (PDS) with ranibizumab, has received FDA approval. Despite this milestone, the PDS was voluntarily withdrawn one year after its introduction due to product quality challenges related to the septum of the device. The PDS was recently returned to the market following modifications to the implant as well as the refill-exchange needle.</p><p><strong>Conclusion: </strong>Although devices with refillable reservoirs have increased challenges related to their inherent complexity, the potential for improved patient outcomes merit further development of this technology.</p>","PeriodicalId":7568,"journal":{"name":"American Journal of Ophthalmology","volume":" ","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}