Translational Vision Science & Technology最新文献_第2页

Using Hierarchical Bayesian Modeling to Enhance Statistical Inference on Contrast Sensitivity.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.17

Yukai Zhao, Luis Andres Lesmes, Michael Dorr, Zhong-Lin Lu

{"title":"Using Hierarchical Bayesian Modeling to Enhance Statistical Inference on Contrast Sensitivity.","authors":"Yukai Zhao, Luis Andres Lesmes, Michael Dorr, Zhong-Lin Lu","doi":"10.1167/tvst.13.12.17","DOIUrl":"10.1167/tvst.13.12.17","url":null,"abstract":"Purpose: The purpose of this study is to introduce a nonparametric hierarchical Bayesian model (HBM) that enables advanced statistical inference on contrast sensitivity (CS) both at individual spatial frequencies (SFs) and across multiple SFs in clinical trials, where CS measurements are crucial for assessing safety and efficacy.Methods: The HBM computes the joint posterior distribution of CS at six Food and Drug Administration-designated SFs across the population, individual, and test levels. It incorporates covariances at both population and individual levels to capture the relationship between CSs across SFs. A Bayesian inference procedure (BIP) is also used to estimate the posterior distribution of CS at each SF independently. Both methods are applied to a quantitative CSF (qCSF) dataset of 112 subjects and compared in terms of precision, test-retest reliability of CS estimates, sensitivity, accuracy, and statistical power in detecting CS changes.Results: The HBM reveals correlations between CSs in pairs of SFs and provides significantly more precise estimates and higher test-retest reliability compared to the BIP. Additionally, it improves the average sensitivity and accuracy in detecting CS changes for individual subjects, as well as statistical power for detecting group-level CS changes at individual and combinations of multiple SFs between luminance conditions.Conclusions: The HBM establishes a comprehensive framework to enhance sensitivity, accuracy, and statistical power for detecting CS changes in hierarchical experimental designs.Translational relevance: The HBM presents a valuable tool for advancing CS assessments in the clinic and clinical trials, potentially improving the evaluation of treatment efficacy and patient outcomes.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"17"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814082","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}

引用次数: 0

Patient-Reported Experience Measurements From Individuals With Inherited Retinal Disorders Involved in Observational Research.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.9

Malena Daich Varela, Shaima Hashem, Dayyanah Sumodhee, Michel Michaelides

{"title":"Patient-Reported Experience Measurements From Individuals With Inherited Retinal Disorders Involved in Observational Research.","authors":"Malena Daich Varela, Shaima Hashem, Dayyanah Sumodhee, Michel Michaelides","doi":"10.1167/tvst.13.12.9","DOIUrl":"10.1167/tvst.13.12.9","url":null,"abstract":"Purpose: Inherited retinal disorders (IRD) are a complex group of conditions. By developing the first patient-reported experience measurement (PREM) questionnaire tailored for individuals with IRD participating in natural history studies, we gathered information on individuals' views of their experience while they are involved in research.Methods: Adults with IRD who (i) were enrolled in a natural history study taking place at Moorfields Eye Hospital (London, UK), (ii) had attended at least two study visits, (iii) the most recent one being less than two weeks before the questionnaire, and (iv) who were not involved in interventional research, were considered for participation.Results: Fifty individuals completed the PREM questionnaire at a mean age of 31.1 ± 11 years old and were diagnosed at a mean age of 14 ± 9.7 years old. Most individuals rated \"getting closer to receiving treatment' as their main motivation to enroll in the study, and their biggest influence was their own curiosity. Individuals were more satisfied with the care they received, and least satisfied with the efficiency of the visit. After validity and reliability assessments, the final PREM was created, with 27 questions and five sections, and Cronbach alpha coefficient between 0.316 and 0.756 in each section.Conclusions: The PREM instrument allowed us to assess the overall satisfaction of individuals with IRD involved in research, detect possible barriers to research participation, and ways of improving our care.Translational relevance: The final version can be included in future research and other sites worldwide, to maintain high quality standards.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"9"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11629914/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142787119","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}

引用次数: 0

A New Approach to Retinal Oxygen Extraction Measurement Based on Laser Speckle Flowgraphy and Retinal Oximetry.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.12

Viktoria Pai, Patrick Janku, Theresa Lindner, Ulrich Graf, Leopold Schmetterer, Gerhard Garhöfer, Doreen Schmidl

{"title":"A New Approach to Retinal Oxygen Extraction Measurement Based on Laser Speckle Flowgraphy and Retinal Oximetry.","authors":"Viktoria Pai, Patrick Janku, Theresa Lindner, Ulrich Graf, Leopold Schmetterer, Gerhard Garhöfer, Doreen Schmidl","doi":"10.1167/tvst.13.12.12","DOIUrl":"10.1167/tvst.13.12.12","url":null,"abstract":"Purpose: Currently, no standard for the measurement of retinal oxygen extraction exists. Here, we present a novel approach for measurement of retinal oxygen extraction based on two commercially available devices, namely laser speckle flowgraphy (LSFG) and retinal oximetry.Methods: The study was conducted in a randomized, double-masked design. Two study days were scheduled for each healthy participant. On one study day, measurements were performed during breathing of 100% oxygen to induce hyperoxia and on the other study day during breathing of 12% oxygen in nitrogen to induce hypoxia. To obtain data for short- and long-term reproducibility, baseline measurements during breathing of room air were performed twice on both study days. Retinal oxygen extraction was calculated from retinal oxygen saturation measurements using the oxygen module of the dynamic vessel analyzer (Imedos, Jena, Germany) and retinal blood flow measurements using LSFG (Nidek, Tokyo, Japan).Results: As expected, breathing of 100% oxygen induced a significant decrease in retinal oxygen extraction of 36% ± 17% (P < 0.001). During hypoxia, retinal oxygen extraction did not change from baseline (P = 0.153). For short-term reproducibility, the intraclass correlation coefficient was excellent (0.910) and good (0.879) for long-term reproducibility. Coefficient of variation between measurements was 9.8% ± 7.0% for short-term and 10.4% ± 8.8% for long-term reproducibility.Conclusions: The data obtained in the present experiments show that the new approach to measure retinal oxygen extraction is valid and reproducible in healthy volunteers.Translational relevance: The technique may become a valuable tool in studying retinal hypoxia in a wide variety of ocular and systemic diseases in the future.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"12"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11636657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808141","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}

引用次数: 0

In Vivo Contactless, Cellular-Resolution Imaging of the Healthy and Pathological Human Limbus With 250-kHz Point-Scanning SD-OCT.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.29

Kostadinka Bizheva, Zohreh Hosseinaee, Kirsten Carter, Denise Hileeto, Brian G Ballios, Luigina Sorbara, Hall F Chew

{"title":"In Vivo Contactless, Cellular-Resolution Imaging of the Healthy and Pathological Human Limbus With 250-kHz Point-Scanning SD-OCT.","authors":"Kostadinka Bizheva, Zohreh Hosseinaee, Kirsten Carter, Denise Hileeto, Brian G Ballios, Luigina Sorbara, Hall F Chew","doi":"10.1167/tvst.13.12.29","DOIUrl":"https://doi.org/10.1167/tvst.13.12.29","url":null,"abstract":"Purpose: To demonstrate that high-seed, ultra-high-resolution spectral-domain optical coherence tomography (SD-OCT) technology can image in vivo fine morphological features in the healthy and pathological human limbus.Methods: A compact, fiberoptic SD-OCT system was developed for imaging the human limbus. It combines ∼1.5-µm isotropic spatial resolution in ocular tissue and an acquisition rate of 250,000 A-scans per second. The imaging probe was outfitted with two microscope objectives to provide flexibility in the choice of wide field of view and extended depth of focus versus high lateral resolution. The clinical potential of the system was evaluated by imaging subjects with limbal stem cell dysfunction (LSCD; n = 4) and healthy controls (n = 6).Results: Limbus images acquired from the healthy controls showed normal cellular structure of the limbal crypts, palisades of Vogt (POVs), and vasculature of the underlying scleral tissue. Images acquired from the LSCD subjects showed distortions or absence of POVs, invasion of highly scattering conjunctival tissue over the limbal and peripheral corneal epithelium, scarring and thinning of the limbal epithelium, and neovascularization.Conclusions: The combination of high OCT spatial resolution and rapid image acquisition rate allows for in vivo, contactless, volumetric visualization of fine morphological details that could be beneficial for the precise diagnosis and grading of LSCD, planning of treatment, and evaluation of the effectiveness of the treatment approaches.Translational relevance: The OCT technology described here could improve the clinical diagnostics and grading of LSCD, preoperative planning, and postoperative evaluation of LSCD subjects, in addition to monitoring the effectiveness of various LSCD treatments.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"29"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142839603","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}

引用次数: 0

Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.32

David S Boyer, Nathan C Steinle, Joel A Pearlman, Cameron M Stone, Courtney Crawford, Sunil Gupta, Pravin U Dugel, Megan E Baldwin, Ian M Leitch

{"title":"Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema.","authors":"David S Boyer, Nathan C Steinle, Joel A Pearlman, Cameron M Stone, Courtney Crawford, Sunil Gupta, Pravin U Dugel, Megan E Baldwin, Ian M Leitch","doi":"10.1167/tvst.13.12.32","DOIUrl":"https://doi.org/10.1167/tvst.13.12.32","url":null,"abstract":"Purpose: Sozinibercept inhibits vascular endothelial growth factors (VEGFs) C and D. This study evaluated outcomes following switching from anti-VEGF-A monotherapy to intravitreal injections of three dose levels of sozinibercept in combination with aflibercept in patients with diabetic macular edema (DME).Methods: A phase 1b, open-label, multicenter dose-escalation study with a 24-week follow-up. Patients received 3 loading doses of aflibercept (2 mg) in combination with sozinibercept (0.3, 1, or 2 mg) once every 4 weeks and were followed through week 24. The primary endpoint was safety, and secondary endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and anatomic changes on imaging.Results: Nine patients received sozinibercept in combination with aflibercept after a mean (SD) of 6.3 (2.4) injections of previous anti-VEGF-A. Sozinibercept combination therapy was well tolerated with no dose-limiting toxicities. Mean change in BCVA at week 12 was +7.7 letters (95% confidence interval [CI], 2-13.3) from baseline (65 letters [SD 5.5]) with a dose response for increasing doses of sozinibercept. At week 12, central subfield thickness (CST) was decreased by -71 µm (95% CI, -117 to -26) from baseline (434 µm [SD 58]), and 6 of 9 (67%) patients had a ≥50% reduction in excess foveal thickness.Conclusions: In prior-treated patients with center-involved DME, switching to sozinibercept in combination with aflibercept was well tolerated with improved visual and anatomic outcomes.Translational relevance: This first-in-human study builds upon basic research by providing safety and preliminary efficacy of sozinibercept (anti-VEGF-C/-D) in combination with aflibercept for DME.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"32"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855273","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}

引用次数: 0

Archetypal Analysis Reveals Consistent Visual Field Patterns for Stimulus Sizes III and V in Glaucoma and NAION.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.15

David Szanto, Michael Wall, Luke X Chong, Brian Woods, Tobias Elze, Jui-Kai Wang, Mona Garvin, Randy Kardon, Mark J Kupersmith

{"title":"Archetypal Analysis Reveals Consistent Visual Field Patterns for Stimulus Sizes III and V in Glaucoma and NAION.","authors":"David Szanto, Michael Wall, Luke X Chong, Brian Woods, Tobias Elze, Jui-Kai Wang, Mona Garvin, Randy Kardon, Mark J Kupersmith","doi":"10.1167/tvst.13.12.15","DOIUrl":"10.1167/tvst.13.12.15","url":null,"abstract":"Purpose: Disorders of the anterior optic nerve cause quantifiable patterns, or archetypes (AT), in visual fields (VFs) obtained using standardized automated perimetry using stimulus size III (size III). VFs with stimulus size V (size V) can reduce retest variability in eyes with moderate to severe loss. We postulated that VF testing using both stimuli would show similar ATs in eyes with glaucoma and nonarteritic anterior ischemic optic neuropathy (NAION).Methods: We used 1969 same-day pairs of 24-2 size III and size V VFs from two datasets. QRK207 is the largest NAION study to date, and the VIPII study measured same-day VFs across many stimulus sizes. We censored raw sensitivities of less than 21 dB for size III and 24 dB for size V and age-standardized to total deviations, before archetypal analysis (AA). We compared the ATs between the two stimuli and the combined data.Results: Using 14 ATs for both glaucoma and NAION, AA captured similar patterns between the two stimuli in both diseases with 87% of AT pairings having a cosine similarity of 0.8 or greater. The combined ATs retained the patterns in the separate stimuli VFs.Conclusions: AA shows that size V VFs provide quantifiable patterns of loss similar to size III. This aids in comparing stimulus sizes for monitoring VF patterns in disease progression.Translational relevance: AA shows similar quantifiable patterns of VF loss with size III or size V, supporting the use of size V to monitor eyes with moderate to severe VF loss.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"15"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814060","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}

引用次数: 0

Author Response: The Distribution of True Visual Field Progression Rates in Glaucoma.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.20

Giovanni Montesano, David P Crabb, David M Wright, Alessandro Rabiolo, Giovanni Ometto, David F Garway-Heath

引用次数: 0

Quantifying the Corneal Nerve Whorl Pattern.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.11

Maryse Lapierre-Landry, Eric Y Lu, Matthew T McPheeters, Made Airanthi K Widjaja-Adhi, David L Wilson, Rony R Sayegh, Patricia R Taylor, Marcin Golczak, Michael W Jenkins

{"title":"Quantifying the Corneal Nerve Whorl Pattern.","authors":"Maryse Lapierre-Landry, Eric Y Lu, Matthew T McPheeters, Made Airanthi K Widjaja-Adhi, David L Wilson, Rony R Sayegh, Patricia R Taylor, Marcin Golczak, Michael W Jenkins","doi":"10.1167/tvst.13.12.11","DOIUrl":"10.1167/tvst.13.12.11","url":null,"abstract":"Purpose: The corneal nerves within the sub-basal nerve plexus (SBNP) display a distinctive whorl-like pattern, a highly dynamic structure that could be a marker of diseases. Previous studies have reported a decrease in whorl nerve density in patients with diabetes, indicating an avenue for noninvasive monitoring of diabetic neuropathy. However, conflicting results have since been reported, highlighting the need for improved quantitative analysis of the corneal whorl. We present an automated algorithm to characterize the whorl shape and test the hypothesis that the whorl organization is affected by diabetic neuropathy.Methods: The SBNP whorl was analyzed as a vector field, from which seven whorl metrics were calculated. The efficacy of these whorl metrics was demonstrated in synthetic images, ex vivo mouse corneas, and in a publicly available dataset of wide-field in vivo confocal microscopy (IVCM) images of diabetic and control subjects. Linear discriminant analysis and the Peacock test were used to test for statistical differences. Our analysis code is made freely available.Results: Using our whorl metrics, we were able to quantify different whorl patterns in our patient population and statistically compare cohorts. We determined that whorl patterns tend to present bilaterally in patients (P < 0.001), but there were no significant differences between whorl patterns in patients with diabetes and control subjects, nor between patients with or without neuropathy symptoms.Conclusions: We present a generalizable framework to statistically compare corneal nerve patterns in cohorts of patients.Translational relevance: SBNP whorl patterns could serve as a noninvasive marker for ocular diseases, whereas few quantitative IVCM endpoints have been identified to date.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"11"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11636656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142802196","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}

引用次数: 0

A Pattern-Based OCT Metric for Glaucoma Detection. 基于模式的青光眼检测 OCT 指标。

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.21

Donald C Hood, Sol La Bruna, Mary Durbin, Chris Lee, Anya Guzman, Tayna Gebhardt, Yujia Wang, Arin L Stowman, Carlos Gustavo De Moraes, Michael Chaglasian, Emmanouil Tsamis

{"title":"A Pattern-Based OCT Metric for Glaucoma Detection.","authors":"Donald C Hood, Sol La Bruna, Mary Durbin, Chris Lee, Anya Guzman, Tayna Gebhardt, Yujia Wang, Arin L Stowman, Carlos Gustavo De Moraes, Michael Chaglasian, Emmanouil Tsamis","doi":"10.1167/tvst.13.12.21","DOIUrl":"10.1167/tvst.13.12.21","url":null,"abstract":"Purpose: To develop and test a novel optical coherence tomography (OCT) metric for the detection of glaucoma based on a logistic regression model (LRM) and known patterns of glaucomatous damage.Methods: The six variables of the LRM were based on characteristic patterns of damage seen on the OCT thickness maps of the ganglion cell layer plus inner plexiform layer (GCL+) and retinal nerve fiber layer (RNFL). Two cohorts were used to develop the LRM. The healthy cohort consisted of 400 individuals randomly selected from a real-world reference database (RW-RDB) of OCT widefield scans from 4932 eyes/individuals obtained from 10 optometry practices. The glaucoma cohort consisted of 207 individuals from the same 10 practices but with OCT reports with evidence of optic neuropathy consistent with glaucoma (ON-G). Specificity was assessed with 396 eyes/individuals from a commercial RDB. Sensitivity was assessed with individuals with ON-G from different optometry practices.Results: For the new LRM metric, the partial area under the reciever operating characteristic curve (AUROC) for specificity >90% was 0.92, and the sensitivity at 95% specificity was 88.8%. These values were significantly greater than those of a previously reported LRM metric (0.82 and 78.1%, respectively) and two common OCT thickness metrics: global circumpapillary RNFL (0.77 and 57.5%, respectively), and global GCL+IPL (0.72 and 47.6%, respectively).Conclusions: The new metric outperformed other OCT metrics for detecting glaucomatous damage.Translational relevance: The new metric has the potential to improve the accuracy of referrals from primary care to specialist care via risk scores and calculators, as well as glaucoma definitions for clinical trials. The individual variables of this model may also aid clinical diagnosis.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"21"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11645750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142818825","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}

引用次数: 0

Clinically Meaningful Change Estimates for the National Eye Institute Visual Function Questionnaire-25 in Patients With Diabetic Macular Edema.

IF 2.6 3区医学

Translational Vision Science & Technology Pub Date : 2024-12-02 DOI: 10.1167/tvst.13.12.27

Neil Bressler, Zdenka Haskova, Audrey Kapre, Brittany Gentile

{"title":"Clinically Meaningful Change Estimates for the National Eye Institute Visual Function Questionnaire-25 in Patients With Diabetic Macular Edema.","authors":"Neil Bressler, Zdenka Haskova, Audrey Kapre, Brittany Gentile","doi":"10.1167/tvst.13.12.27","DOIUrl":"10.1167/tvst.13.12.27","url":null,"abstract":"Purpose: To derive estimates of clinically meaningful change (improvement) on the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in patients with diabetic macular edema (DME) using anchor- and distribution-based methods.Methods: In this exploratory post hoc analysis of data from the RIDE/RISE (NCT00473382/NCT00473330) clinical trials of ranibizumab for DME, the NEI VFQ-25 was completed at baseline and six, 12, 18, and 24 months. Anchor-based (≥5-, ≥10-, and ≥15-letter gain in best-corrected visual acuity [BCVA]) and distribution-based estimates were calculated. Subgroup analyses included outcomes when the study eye was the better- or worse-seeing eye.Results: Baseline characteristics were balanced between the trials (RIDE, N = 382; RISE, N = 377). Anchor-based estimates of clinically meaningful improvement in composite scores (for ≥15-letter gain in BCVA) were 3.78 and 2.23 for RIDE and RISE, respectively. Estimates appeared similar for most subscales: near activities (4.11 and 3.31), distance activities (3.53 and 3.74), driving difficulties (5.15 and 3.15), and vision-specific dependency (4.70 and 1.83). Supportive distribution-based meaningful change composite score estimates also were similar between RIDE and RISE for values based on 0.5 standard deviation (9.85 and 9.70, respectively) or standard error of the mean (5.10 and 4.82, respectively).Conclusions: These analyses suggest improvement of three to five points on the NEI VFQ-25 composite score and four individual subscales as clinically meaningful in patients with DME.Translational relevance: This analysis supports considering these thresholds when assessing the clinical risk-benefit of DME treatment from the patient perspective using the NEI VFQ-25.","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"13 12","pages":"27"},"PeriodicalIF":2.6,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142829694","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}

引用次数: 0