{"title":"Long-term visual outcomes of patients with neovascular age-related macular degeneration treated with anti-VEGF therapy lost to follow-up.","authors":"Ki Tae Nam, Cheolmin Yun","doi":"10.1007/s00417-025-06798-6","DOIUrl":"10.1007/s00417-025-06798-6","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the long-term visual outcomes of patients with neovascular age-related macular degeneration (AMD) who were lost to follow-up (LTFU) during treatment compared with those with continuous follow-up (CFU).</p><p><strong>Methods: </strong>A retrospective study was conducted on patients diagnosed with neovascular AMD who received anti-VEGF therapy from 2010 to 2022. The patients were classified into the long-term LTFU group (LTFU for more than 6 months), the short-term LTFU group (LTFU for 2 months to less than 6 months), and the CFU group. We conducted a comparative analysis of baseline characteristics, factors related to visual prognosis, and differences in the occurrence of severe vision loss.</p><p><strong>Results: </strong>A total of 169 patients were classified into 43 in the long-term LTFU group, 57 in the short-term LTFU group, and 69 in the CFU group. The mean follow-up duration was 57.12 ± 31.68 months. There was no significant difference in baseline visual acuity (logMAR) among the long-term LTFU, short-term LTFU, and CFU groups (0.76 ± 0.54, 0.68 ± 0.51, and 0.72 ± 0.54, respectively; P = 0.734). The final visual acuity was significantly lower in the long-term LTFU group (1.12 ± 0.79) compared with the short-term LTFU group (0.65 ± 0.62) and the CFU group (0.65 ± 0.56) (P < 0.001), and the change in visual acuity was significantly greater in the long-term LTFU group (0.36 ± 0.69) compared with the short-term LTFU group (-0.03 ± 0.64) and the CFU group (-0.07 ± 0.58) (P = 0.001). Long-term LTFU was significantly associated with changes in visual acuity from the baseline to the final visit (P = 0.002) and severe vision loss (P = 0.002).</p><p><strong>Conclusion: </strong>In patients with neovascular AMD, those LTFU for more than six months during treatment had worse long-term visual outcomes compared to those with regular follow-up or shorter LTFU durations.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1837-1845"},"PeriodicalIF":2.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669685","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}
Yue Fu, Yufeng Chen, Xiuqin Li, Lingzi Huang, Lufan Li, Nan Zhang, Yixin Hu, Wen Zeng, Min Ke
{"title":"Risk factors of angle opening after lens extraction in patients with shallow peripheral anterior chamber.","authors":"Yue Fu, Yufeng Chen, Xiuqin Li, Lingzi Huang, Lufan Li, Nan Zhang, Yixin Hu, Wen Zeng, Min Ke","doi":"10.1007/s00417-025-06784-y","DOIUrl":"10.1007/s00417-025-06784-y","url":null,"abstract":"<p><strong>Purpose: </strong>To predict the degree of angle opening after lens extraction (LE) in patients with shallow peripheral anterior chamber.</p><p><strong>Methods: </strong>We collected the ultrasound biomicroscopy (UBM) parameters before and one month after LE retrospectively. The binary logistic regression and artificial neural network (ANN) models of angle opening after LE were established using preoperative UBM parameters, and the predictive factors were screened. The performances of models were evaluated using the area under the receiver operator characteristic curve (AUROC).</p><p><strong>Results: </strong>Patients from the Zhongnan Hospital of Wuhan University were randomized into a training set (n = 91) or a test set (n = 39) for internal validation. External validation employed the entire Zhongnan Hospital cohort as the training set (n = 130) and Dawu County People's Hospital cohort as the test set (n = 30). Both internal and external validation using both models showed that iris curvature (IC), iris-ciliary process angle (ICPA), trabecular-iris angle (TIA), and gender were significantly predictive of the degree of angle opening after LE (p < 0.05). Both models achieved an AUROC of 0.993 (0.997-1.0) in the internal validation training set, and an AUROC of 0.929 (0.774-1.0) in the internal validation test set. In the external validation training set, both models achieved an AUROC of 0.995 (0.984-1.0), while in the external validation test, both models had an AUROC of 0.938 (0.800-1.0).</p><p><strong>Conclusion: </strong>In patients with shallow peripheral anterior chamber, a smaller preoperative TIA, ICPA and IC predicts unsatisfactory angle opening after LE. Female can also be a risk factor for the narrow angle after LE.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1957-1965"},"PeriodicalIF":2.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523254","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}
Philip Keye, Charlotte Evers, Timothy Gläser, Philip Braun, Patrick Thelen, Daniel Böhringer, Stefan Johann Lang, Thomas Reinhard, Jan Lübke
{"title":"Impact of the COVID-19 pandemic on glaucoma surgery in German hospitals.","authors":"Philip Keye, Charlotte Evers, Timothy Gläser, Philip Braun, Patrick Thelen, Daniel Böhringer, Stefan Johann Lang, Thomas Reinhard, Jan Lübke","doi":"10.1007/s00417-025-06787-9","DOIUrl":"10.1007/s00417-025-06787-9","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the quantitative changes in surgical glaucoma care in German hospitals between 2019 and 2022 with special focus on the impact of the COVID-19 pandemic on overall volume and trends within glaucoma surgery.</p><p><strong>Methods: </strong>The quality reports of The Federal Joint Committee (G-BA), containing information on the quantity of surgical glaucoma procedures of 296 German hospitals were obtained in machine-readable form for the years 2019, 2020, 2021 and 2022. We analyzed the annual numbers and proportions of different glaucoma surgery types as categorized by German OPS codes, with special focus on 2020, the first year of the COVID-19 pandemic in Germany.</p><p><strong>Results: </strong>The total number of surgical glaucoma procedures in German hospitals in 2020 decreased by 8.5% compared to 2019 and recovered to pre-pandemic levels in 2021. Within filtration surgery, the number of classic trabeculectomy steadily declined while bleb-forming filtration devices were used more frequently. In all four years, cyclodestructive procedures were the most frequently performed interventions overall.</p><p><strong>Conclusion: </strong>The impact of the COVID-19 pandemic on overall surgical volume, especially in 2020, was substantial but overall moderate and transient. The trend towards minimally invasive procedures and bleb-forming filtration devices accelerated after 2020, resulting in a pronounced decline of classic filtration surgery, such as trabeculectomy.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1967-1975"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"In vivo assessment of regional scleral stiffness by shear wave elastography and its association with choroid and retinal nerve fiber layer characteristics in high myopia.","authors":"Ying Yuan, Fang Li, Weijung Ten, Chengcheng Jin, Yue Wu, Yuying Liu, Bilian Ke","doi":"10.1007/s00417-024-06679-4","DOIUrl":"10.1007/s00417-024-06679-4","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the posterior scleral stiffness of different regions in high myopic eyes and to explore its associations with macular choroidal and peripapillary retinal nerve fiber layer (pRNFL) thickness and vasculature.</p><p><strong>Methods: </strong>Thirty subjects with high myopic eyes and 30 subjects with low myopic eyes were included in this study. The elastic modulus of the macular and peripapillary sclera at the temporal, nasal, superior and inferior regions were determined via shear wave elastography (SWE). Optical coherence tomography and angiography (OCT/OCTA) centered on the fovea and optic disc was obtained by using a commercially available swept-source OCT/OCTA device. Built-in automated software was used to quantify macular subfovea choroidal vessel volume (SFCVV), macular subfovea choroidal thickness (SFCT) and pRNFL thickness.</p><p><strong>Results: </strong>The SWE results demonstrated that high myopic eyes had significantly lower macular and peripapillary scleral elastic modulus than low myopic eyes (P < 0.001). The reduction in the elastic modulus was slightly greater in the temporal peripapillary region, followed by the superior peripapillary, inferior and nasal peripapillary regions (P > 0.05). The linear regression analysis demonstrated a significant association between the posterior scleral elastic modulus and SFCT and inferior pRNFL thickness (P < 0.001).</p><p><strong>Conclusion: </strong>High myopic eyes had weakened posterior scleral stiffness. The regional change in the elastic modulus was associated with the SFCT and inferior quadrant pRNFL thickness. This novel in vivo quantitative assessment of scleral stiffness via SWE may help to characterize the underlying pathologic mechanism of scleral biomechanics on choroid and pRNFL changes in high myopia.</p><p><strong>Key messages: </strong>WHAT IS KNOWN : Previous studies reported significant choroid thickness and peripapillary nerve fiber layer thickness decrease in high myopia The scleral stiffness is weakened in myopic eyes WHAT IS NEW : Shear wave elastography (SWE) is a novel tool to detect posterior scleral biomechanics in myopic eyes in vivo Stiffness of the posterior sclera at macular and peripapillary regions is lower in high myopic than in low myopic eyes The posterior scleral stiffness is correlated with subfovea choroidal thickness and inferior quadrant peripapillary nerve fiber layer thickness.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"2059-2067"},"PeriodicalIF":2.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983201","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":"Modified double-flanged technique in the management of dislocated posterior intraocular lenses.","authors":"Mehmet Icoz, Sevde Akcay Usta","doi":"10.1007/s00417-025-06795-9","DOIUrl":"10.1007/s00417-025-06795-9","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the modified double-flanged technique in cases of subluxated foldable single-piece intraocular lenses (IOLs).</p><p><strong>Methods: </strong>This retrospective study was conducted on 14 eyes of 14 patients.The following steps were performed in the surgical technique, respectively;the dislocated foldable single-piece IOL was repositioned into the anterior chamber, and the haptic was extracted through the corneal main incision.A 27-gauge needle was passed through the widest part of the haptic, close to the haptic-optic junction.A 6.0 polypropylene suture was passed through the needle. For the same process on the other haptic, the IOL was rotated 180 degrees.The polypropylene part of the created haptic-polypropylene complex was extracted through the scleral tunnel using a 26-gauge needle as a guide. The 1.5 mm tips of the polypropylene were cauterized to form flanges, which were then embedded into the sclera. The preoperative and postoperative first and sixth month ophthalmological findings were evaluated.</p><p><strong>Results: </strong>Both uncorrected visual acuity and best-corrected visual acuity were significantly higher at the postoperative sixth-month follow-up(p < 0.001).Possible causes of IOL subluxation; were pseudoexfoliation in five patients (36%),complicated cataract surgery in three patients (21%),trauma in two patients (14%) and no cause was found in four patients (29%). Of the 28 flanges, 24 (86%) were located intrasclerally, while four (14%) were in the subtenon space.Elevated intraocular pressure was detected in one case (7%) in the early postoperative period, and cystoid macular edema was noted in two cases (14%).</p><p><strong>Conclusion: </strong>This study demonstrated that the modified double-flanged technique could be effectively and safely applied in cases of subluxated foldable single-piece IOL.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1925-1932"},"PeriodicalIF":2.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604687","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":"Comparison of the clinical outcomes after manual capsulorhexis on one eye and precision pulse capsulotomy on the other eye.","authors":"Ho Sik Hwang, Hyun Seung Kim, Eun Chul Kim","doi":"10.1007/s00417-025-06783-z","DOIUrl":"10.1007/s00417-025-06783-z","url":null,"abstract":"<p><strong>Purpose: </strong>To compare the clinical outcomes after manual continuous curvilinear capsulorhexis (CCC) on one eye and precision pulse capsulotomy (PPC) on the other eye in cataract surgery.</p><p><strong>Methods: </strong>60 eyes from 30 patients who underwent manual capsulorhexis on one eye (CCC group, N = 30) and precision pulse capsulotomy on the other eye (PPC group, N = 30) were retrospectively enrolled. Uncorrected and corrected visual acuity, manifest refraction, and corneal endothelial cell density were evaluated.</p><p><strong>Results: </strong>There were also no significant differences between the two groups according to the change in the corneal endothelial cell density at 3 months after cataract surgery (p > 0.05). The horizontal diameter (mm) and area (mm2) of the capsulotomy of the PPC group were significantly smaller than those of the CCC at postoperative 1 day and 3 months (P < 0.05). The circularity of PPC group was significantly better than that of the CCC at postoperative 1 day and 3 months (P < 0.05) (Table 4). Postoperative reduction of the capsulotomy area of the PPC group (6.64 ± 1.47) was higher than that of the CCC group (3.48 ± 1.21) from 1 day to 3 months after cataract surgery (P < 0.05).</p><p><strong>Conclusions: </strong>PPC was as safe as CCC and more efficient than CCC for making perfectly round capsulotomy. The initial capsulotomy size of PPC was smaller than that of CCC. PPC size decreased more than CCC after several months because it might damage the anterior capsule with thermal energy.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1907-1913"},"PeriodicalIF":2.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143500629","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}
Young In Yun, Richul Oh, Joo Youn Oh, Hyuk Jin Choi, Mee Kum Kim, Chang Ho Yoon
{"title":"Longitudinal changes in ocular biometry and their effect on intraocular lens power calculation accuracy in cataract patients.","authors":"Young In Yun, Richul Oh, Joo Youn Oh, Hyuk Jin Choi, Mee Kum Kim, Chang Ho Yoon","doi":"10.1007/s00417-025-06775-z","DOIUrl":"10.1007/s00417-025-06775-z","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the changes in ocular biometry over time and their impact on intraocular lens (IOL) calculation in adult Korean patients with cataracts.</p><p><strong>Methods: </strong>Inclusion criteria were patients who underwent two consecutive ocular biometric measurements spaced more than one year apart using the IOLMaster 700 between November 2019 and February 2024 at a tertiary hospital in Seoul, Korea. Longitudinal changes in ocular biometry were evaluated. Predictive errors were compared among patients who underwent cataract surgery using the SRK/T, Kane, Barrett Universal II, Cook K6, EVO, Hill-RBF, Hoffer QST, and Pearl DGS formulas.</p><p><strong>Results: </strong>A total of 448 eyes from 448 patients were included. Ocular biometry measured over an average interval of 23.4 months showed that with increasing age, axial length elongated (0.04 ± 0.10 mm, p < 0.001), and the magnitude of total corneal astigmatism increased (0.04 ± 0.39 D, p = 0.018). The mean absolute predictive errors of the final measurements were significantly smaller compared to the initial measurements in the Barrett Universal II, EVO, Kane, and Pearl DGS formulas (difference of -0.05 D, -0.05 D, -0.06 D, and - 0.05 D, respectively). In the subgroup of eyes with an axial length of 25 mm or longer, the final measurements showed even greater reduction in mean absolute predictive errors across multiple formulas, including Barrett Universal II, Cook K6, EVO, Hill-RBF, Hoffer QST, Kane, and Pearl DGS, with reductions of -0.11 D, -0.11 D, -0.10 D, -0.08 D, -0.10 D, -0.09 D and - 0.10 D, respectively.</p><p><strong>Conclusions: </strong>Axial length increases and corneal curvature changes with aging. IOLMaster 700 ocular biometry results measured closer to the date of surgery were more accurate in IOL power calculation than those measured more than one year earlier, with the greatest improvement observed in myopic eyes. Therefore, it is recommended to repeat IOLMaster 700 biometry before surgery if the previous measurements were taken more than a year ago.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1915-1924"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthias Gutfleisch, Britta Heimes-Bussmann, Sökmen Aydin, Ratko Petrovic, Alexander Loktyushin, Masahito Ohji, Kanji Takahashi, Annabelle A Okada, Paula Scholz, Hossam Youssef, Ulrike Bauer-Steinhusen, Tobias Machewitz, Kai Rothaus, Albrecht Lommatzsch
{"title":"A post-hoc analysis of intravitreal aflibercept-treated nAMD patients from ARIES & ALTAIR: predicting treatment intervals and frequency for aflibercept treat-and-extend therapy regimen using machine learning.","authors":"Matthias Gutfleisch, Britta Heimes-Bussmann, Sökmen Aydin, Ratko Petrovic, Alexander Loktyushin, Masahito Ohji, Kanji Takahashi, Annabelle A Okada, Paula Scholz, Hossam Youssef, Ulrike Bauer-Steinhusen, Tobias Machewitz, Kai Rothaus, Albrecht Lommatzsch","doi":"10.1007/s00417-025-06812-x","DOIUrl":"10.1007/s00417-025-06812-x","url":null,"abstract":"<p><strong>Purpose: </strong>To predict potential treatment need during treat-and-extend (T&E) anti-vascular endothelial growth factor (VEGF) treatment in neovascular age-related macular degeneration (nAMD) using an artificial intelligence (AI) model trained using transfer learning.</p><p><strong>Methods: </strong>ARIES and ALTAIR were randomized controlled Phase 3b/4 trials assessing intravitreal aflibercept (IVT-AFL) in patients with nAMD. Following treatment initiation with three monthly injections of IVT-AFL, treatment intervals were re-assessed continuously during the study based on prespecified criteria. In this post- hoc analysis, spectral domain optical coherence tomography (SD-OCT) scans from Week (Wk) 8 and Wk 16 visits from patients treated with T&E regimens of 2 mg IVT-AFL over 2 years were utilized to predict individual treatment intervals and frequency. Automated image segmentation of the SD-OCT scans was performed, predictive models of treatment intervals and frequency were developed using machine learning or logistic regression methods, and their performance was evaluated using a fivefold cross-validation. A transfer learning technique was used to adapt existing AI models previously trained on a pro-re-nata therapy regimen to the T&E dataset.</p><p><strong>Results: </strong>In total, 205 ARIES and 112 ALTAIR patient datasets were used for training and evaluation. The following results were achieved with an AI model trained using transfer learning (for ARIES) and logistic regression (for ALTAIR). For prediction of the first treatment interval (short [< 12 weeks] or long [≥ 12 weeks]) following treatment initiation, at Visit 4 (Wk 16), the AI model achieved an area under the receiver operating characteristic curve (AUC) of 0.87 and 0.78 for ARIES and ALTAIR, respectively. For assessment of the individual frequency of IVT-AFL in the first and second study years, the model achieved an AUC of 0.84 and 0.79, respectively, for ARIES, and 0.79 and 0.78, respectively, for ALTAIR. For prediction of the last intended individual treatment interval at the end of Year 2, the AI model achieved an AUC of 0.74 and 0.77 for ARIES and ALTAIR, respectively.</p><p><strong>Conclusion: </strong>AI trained using transfer learning can be used to predict potential treatment needs for anti-VEGF treatment in nAMD based on SD-OCT scans at Wk 8 and Wk 16, supporting medical decisions on interval adjustments and optimizing individualized IVT-AFL treatment regimens.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1885-1897"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xin Li, Jun Yuan, Jia Qi, Kunwei Ruan, Bin Li, Yanping Dan, Yong Zhang
{"title":"The rAAV2-ND1 gene therapy for Leber hereditary optic neuropathy.","authors":"Xin Li, Jun Yuan, Jia Qi, Kunwei Ruan, Bin Li, Yanping Dan, Yong Zhang","doi":"10.1007/s00417-025-06776-y","DOIUrl":"10.1007/s00417-025-06776-y","url":null,"abstract":"<p><strong>Purpose: </strong>No effective treatment for leber hereditary optic neuropathy (LHON) caused by ND1 mutation is available.This study evaluated the safety and efficacy of a single unilateral intravitreal injection rAAV2-ND1 in various doses for the treatment of LHON.</p><p><strong>Methods: </strong>Twelve patients with LHON (ND1 mutation) in two groups with six participants each.The low-dose group received injection of rAAV2-ND1 in a dose of 1.5 × 10<sup>8</sup> vg/eye while the high-dose group received 1.5 × 10<sup>9</sup> vg/eye.The safety endpoint was the incidence of adverse events (AEs).The primary efficacy endpoint was changes of best corrected visual acuity (BCVA).The secondary efficacy endpoints were improvement in visual field (VF), visual field index (VFI), and mean deviation (MD) and change in retinal nerve fiber layer (RNFL) thickness.</p><p><strong>Results: </strong>In total,11 mild eye-related AEs occurred in the participants in both groups, and short-term drug treatment returned to normal.The difference was statistically significant in BCVA of the injected eyes in the low-dose group between 12 months after treatment and at baseline.The differences in BCVA of the uninjected eyes in the high-dose group between baseline and 3 months or 6 months after treatment were statistically significant.At 12 months after treatment, the rate of improvement in BCVA for the injected eyes in the low-dose groups was 66.7% (4/6),while BCVA for the uninjected eyes in the high-dose groups was 50.0% (3/6),and patients in both groups had binocular VF (VFI, MD) and RNFL thicknesses that did not significantly differ from baseline.</p><p><strong>Conclusion: </strong>Preliminary clinical evidence shows that rAAV2-ND1 ophthalmic injection is a safe and effective treatment for LHON due to ND1 mutation.</p><p><strong>Trial registration: </strong>Trial registration number: ChiCTR2000041574, Date:12/29/2020.</p>","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"2017-2024"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373527/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alica Hartmann, Stephanie D Grabitz, Philipp S Wild, Karl J Lackner, Thomas Münzel, Jasmin Ghaemi Kerahrodi, Susanne Singer, Katharina Geschke, Jörn M Schattenberg, Stavros Konstantinides, Norbert Pfeiffer, Alexander K Schuster
{"title":"Gender-specific changes in vision-related quality of life over time - results from the population-based Gutenberg Health Study.","authors":"Alica Hartmann, Stephanie D Grabitz, Philipp S Wild, Karl J Lackner, Thomas Münzel, Jasmin Ghaemi Kerahrodi, Susanne Singer, Katharina Geschke, Jörn M Schattenberg, Stavros Konstantinides, Norbert Pfeiffer, Alexander K Schuster","doi":"10.1007/s00417-025-06741-9","DOIUrl":"10.1007/s00417-025-06741-9","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate potential gender- and age-specific changes over time in vision-related quality of life (VRQoL) on a population-based level. Further, factors associated with changes in VRQoL will be explored.</p><p><strong>Methods: </strong>The Gutenberg Health Study is a population-based, prospective, observational, single-center cohort study in Germany. VRQoL was quantified at baseline and 5-year follow-up using the visual function scale (VFS) and socio-emotional scale (SES-VRQoL). VFS and SES-VRQoL are calculated using the \"National Eye Institute 25-Item Visual Functioning Questionnaire\" (NEI-VFQ-25). Both scales range from 0 to 100, 0 corresponds to the sum that would be achieved if a participant had answered all items with the worst performance, and 100 corresponds to the sum of all items answered with the best possible performance. Distance-corrected visual acuity was measured in both eyes. Univariable and multivariable linear regression analyses were conducted to identify ophthalmic and sociodemographic predictors of VRQoL.</p><p><strong>Results: </strong>A total of 10,152 participants (mean age 54.2 years; 49.2% female) were included in the analysis. The mean visual functioning decreased from 89.6 (IQR: 81.3, 95.1) at baseline to 85.9 (IQR: 79.2, 92.6) at 5-year follow-up in the VFS (p < 0.001). Participants' socio-emotional well-being remained the same from baseline to 5-year follow-up in the SES-VRQoL. In multivariable linear regression analysis, older age (0.03, p = 0.002) and female gender (-1.00, p < 0.001) were associated with a VFS change. Higher baseline socioeconomic status was associated with a slightly positive increase in VFS (0.07, p = 0.001). Deterioration of visual acuity in the better and worse-seeing eye was associated with negative VFS change over 5 years (better-seeing eye: -5.41, p < 0.001, worse-seeing eye: -7.35, p < 0.001). Baseline socioeconomic status was associated with SES-VRQoL change (0.06, p < 0.001). The negative change in visual acuity showed an association with negative SES-VRQoL in the better (-4.15, p < 0.001) and worse-seeing eye (-3.75, p < 0.001). Stratification of the regression models by age and gender showed greater reductions in VFS scores with visual acuity changes in participants aged 65 years or older and a more pronounced decrease in female participants over 5 years.</p><p><strong>Conclusions: </strong>This study demonstrated an association between visual acuity change and change in VRQoL over 5 years, with a greater decrease in female participants and participants aged 65 years or older. The better-seeing eye and the worse-seeing eye both had an impact on changes in VRQoL.</p><p><strong>Key messages: </strong>What is known Previous studies have predominantly used cross-sectional designs to investigate the correlation between visual acuity and vision-related quality of life, with limited insights into how visual acuity changes over time affect vision-related quality ","PeriodicalId":12795,"journal":{"name":"Graefe’s Archive for Clinical and Experimental Ophthalmology","volume":" ","pages":"1825-1835"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12373681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}