Mary Elizabeth Hartnett, MD

All Publications

• Retinal racemose hemangioma presenting with a chorioretinal anastomosis. American journal of ophthalmology case reports Soetikno, B. T., Ghoraba, H., Brant, A., DeBoer, C., Guo, L., Shue, A., Hartnett, M. E. 2024; 36: 102188

  Abstract

  Purpose: To report a case of neovascular glaucoma in an 8-year-old male, secondary to a racemose hemangioma without associated intracranial arteriovenous malformation, highlighting the challenges in management and novel findings on optical coherence tomography angiography (OCTA).Observations: An 8-year-old male initially presented with pain, redness, and blurred vision in the right eye. The patient was diagnosed with secondary neovascular glaucoma due to a racemose hemangioma. Urgent interventions included intravitreal bevacizumab injection and tube shunt surgery for persistently high intraocular pressure. Pars plana vitrectomy and scatter laser photocoagulation were eventually performed to manage a tractional retinal detachment and peripheral ischemia, respectively. OCTA imaging revealed a racemose hemangioma with a unique chorioretinal anastomosis.Conclusions and Importance: We present a rare pediatric case of neovascular glaucoma secondary to a racemose hemangioma with significant peripheral ischemia and an unusual chorioretinal anastomosis. The discovery of a chorioretinal anastomosis on OCTA suggests a potentially severe variant of racemose hemangioma.

  View details for DOI 10.1016/j.ajoc.2024.102188

  View details for PubMedID 39502457

• Clinical Characteristics and Treatment Outcomes in Unilateral Coats disease - a Global Collaborative Study. Ophthalmology. Retina Tsai, A. S., Wang, C. T., Lee, T. C., Nagiel, A., Matsunaga, K., Harper, C. A., Wood, E. H., Kim, S. J., Hwang, S., Shapiro, M. J., Blair, M. P., Toth, C. A., Valikodath, N., Martinez-Castellanos, M. A., Trese, M. G., Capone, A., Drenser, K., Tauqeer, Z., Besirli, C. G., Eton, E., Hartnett, M. E., Bair, C., Kennedy, B., Kusaka, S., Mano, F., Chang, E. Y., Rao, P., Hunt, P. J., Walsh, M. K., Moore, S., Sears, J. E., Abraham, J., Schulgit, M., Vagaggini, T., Quiram, P. A., Vavvas, D., Patel, N. A., Hoyek, S., Chan, R. V., Challa, N., Mendel, T., Dewan, K. S., Rogers, D. L., Amphornphruet, A., Wu, W. C. 2024

  Abstract

  To evaluate the clinical outcomes and prognostic factors in unilateral Coats disease in the era of anti-VEGF therapy.Global, multicenter, retrospective case series.656 eyes of 656 subjects with Coats disease were included in this study. Exclusion criteria were Coats disease secondary to retinitis pigmentosa as well as bilateral cases.Clinical data from patients with Coats disease were collected from 20 ophthalmic practices around the world. We compared early-stage (stage 1-2) and advanced-stage (stage 3-5) Coats disease in terms of clinical characteristics and treatment modalities.Functional outcomes include achieving visual acuity (VA) of 0.3 logMAR or better and VA improvement or stability. Anatomical failure was defined as the development of phthisis, chronic retinal detachment, massive fibrosis, or the requirement for enucleation.Subjects with early-stage disease were significantly older, with a mean age of 17.4 ± 17.8 years, compared to 7.1 ± 7.1 years in the advanced-stage group (p < 0.001). There was a male predominance in both early and advanced stages (84.7%). Advanced disease was associated with a higher incidence of strabismus (20.2% vs. 6.7%, p < 0.001) and leukocoria (12.3% vs. 3.2%, p < 0.001). More subjects with early-stage disease received laser photocoagulation as monotherapy (44.7% vs. 21.1%, p < 0.001). Additionally, early-stage disease received more sessions of intravitreal anti-VEGF injections as adjunct therapy (4.4 ± 6.2 vs. 2.7 ± 2.1, p = 0.005). Factors associated with poorer functional outcomes included worse presenting visual acuity, advanced disease stage, and the presence of a foveal nodule. Worse presenting visual acuity and advanced disease stage was associated with lower likelihood of anatomical success while combination therapy increased the odds of anatomical success.Unilateral Coats disease predominantly affects males, regardless of disease stage. Identifying a foveal nodule is crucial for visual prognosis. Laser photocoagulation remains the primary treatment. While anti-VEGF may prevent enucleation, its role in early-stage disease requires further clarification.

  View details for DOI 10.1016/j.oret.2024.11.017

  View details for PubMedID 39613161

• Oral HIF-2alpha Inhibitor Belzutifan in Ocular von Hippel-Lindau Disease: Subgroup Analysis of the Single-Arm Phase 2 LITESPARK-004 Study. Ophthalmology Wiley, H. E., Srinivasan, R., Maranchie, J. K., Chhablani, J., Bondergaard Iversen, A. B., Kruse, A., Jonasch, E., Gombos, D. S., Else, T., Demirci, H., Maughan, B. L., Hartnett, M. E., Coleman, H. R., Fu, W., Perini, R. F., Liu, Y., Linehan, W. M., Chew, E. Y., LITESPARK-004 Investigator Group - Ocular VHL, Bondergaard Iversen Anders Kruse, A. B., Welsh, S., Jonasch, E., Gombos, D. S., Srinivasan, R., Linehan, W. M., Chew, E. Y., Wiley, H., Thavikulwat, A. T., Keenan, T. D., Bellur, S., Mac, L., Cukras, C. A., Maughan, B. L., Hartnett, M. E., Hakan Demirci, T. E., Maranchie, J. K., Chhablani, J. 2024

  Abstract

  OBJECTIVE: To report the efficacy of oral HIF-2alpha inhibitor belzutifan in participants with von Hippel-Lindau disease-associated retinal hemangioblastomas in LITESPARK-004.DESIGN: Subgroup analysis of the phase 2, single-arm, open-label LITESPARK-004 study.PARTICIPANTS: Adults with ≥1 von Hippel-Lindau disease-associated measurable renal cell carcinoma tumor not requiring immediate surgical intervention were eligible.METHODS AND INTERVENTION: Participants received oral belzutifan 120 mg once daily until disease progression or unacceptable treatment-related toxicity.MAIN OUTCOME MEASURES: Efficacy of belzutifan in retinal hemangioblastomas was a secondary end point, measured as response (improved, stable, or progressed) by independent reading center certified graders based on color fundus imaging performed every 12 weeks using the investigator's preferred imaging standards. Additional assessments, where available, included optical coherence tomography and ultra-widefield fluorescein angiography.RESULTS: Among 61 participants in LITESPARK-004, 12 had ≥1 evaluable active retinal hemangioblastoma in 16 eyes at baseline per independent reading center. As of April 1, 2022, the median follow-up for participants with ocular von Hippel-Lindau disease at baseline was 37.3 months. All 16 eyes were graded as improved, with a response rate of 100.0% (95% confidence intervals, 79.4-100.0). No new retinal hemangioblastomas or ocular disease progression were reported as of data cutoff date. Eight participants had additional multimodal eye assessments performed at the National Institutes of Health study site. Among this subgroup, 10 of 24 hemangioblastomas in 8 eyes of 6 participants measured ≥500 mum in greatest linear dimension at baseline and were further analyzed. All 10 hemangioblastomas had a mean area reduction of ≥15% by month 12 and ≥30% by month 24.CONCLUSIONS: Belzutifan showed promising activity against ocular von Hippel-Lindau disease, including capacity to control retinal hemangioblastomas, with effects sustained for >2 years while on treatment.

  View details for DOI 10.1016/j.ophtha.2024.05.024

  View details for PubMedID 38849055

• The Moran AMD Genetic Testing Assessment (MAGENTA) Study - Baseline Report Addo, E., Lucci, L., Sauer, L., Hartnett, M., Bernstein, P. S. ASSOC RESEARCH VISION OPHTHALMOLOGY INC. 2024

  View details for Web of Science ID 001313316203022

• 7-Ketocholesterol-induce IQGAP1 mediated endothelial-mesenchymal transition of choroidal endothelial cells Yang, S., Zhao, C., Jacob, J., Suresh, A., Nguyen, J., Ramshekar, A., Hartnett, M., Yang, S., Zhao, C., Jacob, J., Suresh, A., Nguyen, J., Ramshekar, A., Hartnett, M. ASSOC RESEARCH VISION OPHTHALMOLOGY INC. 2024

  View details for Web of Science ID 001313316204244

• Genome-wide association identifies novel ROP risk loci in a multiethnic cohort. Communications biology Li, X., Owen, L. A., Taylor, K. D., Ostmo, S., Chen, Y. I., Coyner, A. S., Sonmez, K., Hartnett, M. E., Guo, X., Ipp, E., Roll, K., Genter, P., Chan, R. V., DeAngelis, M. M., Chiang, M. F., Campbell, J. P., Rotter, J. I., i-ROP Consortium, Campbell, J. P., Ostmo, S., Coyner, A., Young, B. K., Kim, S. J., Sonmez, K., Schelonka, R., Chiang, M. F., Chan, R. V., Jonas, K., Kolli, B., Horowitz, J., Coki, O., Eccles, C., Sarna, L., Orlin, A., Berrocal, A., Negron, C., Denser, K., Cumming, K., Osentoski, T., Check, T., Zajechowski, M., Lee, T., Nagiel, A., Kruger, E., McGovern, K., Contractor, D., Havunjian, M., Simmons, C., Murthy, R., Galvis, S., Rotter, J., Chen, I., Li, X., Taylor, K., Roll, K., Owen, L., Lucci, L., Hartnett, M. E., Moshfeghi, D., Nunez, M., Weinberg-Smith, Z., Kalpathy-Cramer, J., Erdogmus, D., Ioannidis, S., Martinez-Castellanos, M. A., SalinasLongoria, S., Romero, R., Arriola, A., Olguin-Manriquez, F., Meraz-Gutierrez, M., Dulanto-Reinoso, C. M., Montero-Mendoza, C. 2024; 7 (1): 107

  Abstract

  We conducted a genome-wide association study (GWAS) in a multiethnic cohort of 920 at-risk infants for retinopathy of prematurity (ROP), a major cause of childhood blindness, identifying 1 locus at genome-wide significance level (p<5*10-8) and 9 with significance of p<5*10-6 for ROP ≥ stage 3. The most significant locus, rs2058019, reached genome-wide significance within the full multiethnic cohort (p=4.96*10-9); Hispanic and European Ancestry infants driving the association. The lead single nucleotide polymorphism (SNP) falls in an intronic region within the Glioma-associated oncogene family zinc finger 3 (GLI3) gene. Relevance for GLI3 and other top-associated genes to human ocular disease was substantiated through in-silico extension analyses, genetic risk score analysis and expression profiling in human donor eye tissues. Thus, we identify a novel locus at GLI3 with relevance to retinal biology, supporting genetic susceptibilities for ROP risk with possible variability by race and ethnicity.

  View details for DOI 10.1038/s42003-023-05743-9

  View details for PubMedID 38233474

• Elucidating the role of MEMO1 in VEGFR2-triggered signaling in retinal microvascular endothelial cells Ramshekar, A., Wallace-Carrete, C., Zaugg, C. J., Nguyen, J., Hartnett, M. ASSOC RESEARCH VISION OPHTHALMOLOGY INC. 2023

  View details for Web of Science ID 001053758303176

• Federated Learning for Multicenter Collaboration in Ophthalmology: Improving Classification Performance in Retinopathy of Prematurity Lu, C., Hanif, A., Singh, P., Chang, K., Coyner, A. S., Brown, J. M., Ostmo, S., Chan, R., Rubin, D., Chiang, M. F., Campbell, J., Kalpathy-Cramer, J., Imaging Informatics Retinopathy Pr ELSEVIER SCIENCE INC. 2022: 964-965

  View details for Web of Science ID 000841489000012

• Federated learning for multi-center collaboration in ophthalmology: implications for clinical diagnosis and disease epidemiology. Ophthalmology. Retina Hanif, A., Lu, C., Chang, K., Singh, P., Coyner, A. S., Brown, J. M., Ostmo, S., Chan, R. P., Rubin, D., Chiang, M. F., Kalpathy-Cramer, J., Campbell, J. P., Imaging and Informatics in Retinopathy of Prematurity Consortium, Chiang, M. F., Ostmo, S., Kim, S. J., Sonmez, K., Campbell, J. P., Schelonka, R., Coyner, A., Chan, R. P., Jonas, K., Kolli, B., Horowitz, J., Coki, O., Eccles, C., Sarna, L., Orlin, A., Berrocal, A., Negron, C., Denser, K., Cumming, K., Osentoski, T., Check, T., Zajechowski, M., Lee, T., Nagiel, A., Kruger, E., McGovern, K., Contractor, D., Havunjian, M., Simmons, C., Murthy, R., Galvis, S., Nnp, Rotter, J., Chen, I., Li, X., Taylor, K., Roll, K., Hartnett, M. E., Owen, L., Moshfeghi, D., Nunez, M., Wennber-Smith, Z., Kalpathy-Cramer, J., Erdogmus, D., Ioannidis, S., Martinez-Castellanos, M. A., Salinas-Longoria, S., Romero, R., Arriola, A., Olguin-Manriquez, F., Meraz-Gutierrez, M., Dulanto-Reinoso, C. M., Montero-Mendoza, C. 2022

  Abstract

  OBJECTIVE OR PURPOSE: To utilize a deep learning (DL) model trained via federated learning (FL), a method of collaborative training without sharing patient data, to delineate institutional differences in clinician diagnostic paradigms and disease epidemiology in retinopathy of prematurity (ROP).DESIGN: Evaluation of a diagnostic test or technology SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: 5,245 patients with wide-angle retinal imaging from the neonatal intensive care units of 7 institutions as part of the Imaging and Informatics in ROP (i-ROP) study. Images were labeled with the clinical diagnosis of plus disease (plus, pre-plus, no plus) that was documented in the chart, and a reference standard diagnosis (RSD) determined by three image-based ROP graders and the clinical diagnosis.METHODS, INTERVENTION OR TESTING: Demographics (birthweight [BW], gestational age [GA]), and clinical diagnoses for all eye exams were recorded from each institution. Using a FL approach, a DL model for plus disease classification was trained using only the clinical labels. The three class probabilities were then converted into a vascular severity score (VSS) for each eye exam, as well as an "institutional VSS" in which the average of the VSS values assigned to patients' higher severity ("worse") eyes at each exam was calculated for each institution.MAIN OUTCOME MEASURES: We compared demographics, clinical diagnosis of plus disease, and institutional VSS between institutions using the McNemar Bowker test, two-proportion Z test and one-way ANOVA with post-hoc analysis by Tukey-Kramer test. Single regression analysis was performed to explore the relationship between demographics and VSS.RESULTS: We found that the proportion of patients diagnosed with pre-plus disease varied significantly between institutions (p<0.00l). Using the DL-derived VSS trained on the data from all institutions using FL, we observed differences in the institutional VSS, as well as level of vascular severity diagnosed as no plus (p<0.001) across institutions. A significant, inverse relationship between the institutional VSS and the mean GA was found (p=0.049, adjusted R2=0.49).CONCLUSIONS: A DL-derived ROP VSS developed without sharing data between institutions using FL identified differences in the clinical diagnosis of plus disease, and overall levels of ROP severity between institutions. FL may represent a method to standardize clinical diagnosis and provide objective measurement of disease for image-based diseases.

  View details for DOI 10.1016/j.oret.2022.03.005

  View details for PubMedID 35304305

• Federated learning for multi-center collaboration in ophthalmology: improving classification performance in retinopathy of prematurity. Ophthalmology. Retina Lu, C., Hanif, A., Singh, P., Chang, K., Coyner, A. S., Brown, J. M., Ostmo, S., Chan, R. P., Rubin, D., Chiang, M. F., Campbell, J. P., Kalpathy-Cramer, J., Imaging and Informatics in Retinopathy of Prematurity Consortium 2022

  Abstract

  OBJECTIVE: To compare the performance of deep learning (DL) classifiers for the diagnosis of plus disease in retinopathy of prematurity (ROP) trained using two methods of developing models on multi-institutional datasets: centralizing data versus federated learning (FL) where no data leaves each institution.DESIGN: Evaluation of a diagnostic test or technology.SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: DL models were trained, validated, and tested on 5,255 wide-angle retinal images in the neonatal intensive care units of 7 institutions as part of the Imaging and Informatics in ROP (i-ROP) study. All images were labeled for the presence of plus, pre-plus, or no plus disease with a clinical label, and a reference standard diagnosis (RSD) determined by three image-based ROP graders and the clinical diagnosis.METHODS, INTERVENTION OR TESTING: We compared the area under the receiver operating characteristic curve (AUROC) for models developed on multi-institutional data, using a central approach, then FL, and compared locally trained models to either approach. We compared model performance (kappa) with label agreement (between clinical and RSD), dataset size and number of plus disease cases in each training cohort using Spearman's correlation coefficient (CC).MAIN OUTCOME MEASURES: Model performance using AUROC and linearly-weighted kappa.RESULTS: Four settings of experiment: FL trained on RSD against central trained on RSD, FL trained on clinical labels against central trained on clinical labels, FL trained on RSD against central trained on clinical labels, and FL trained on clinical labels against central trained on RSD (p=0.046, p=0.126, p=0.224, p=0.0173, respectively). 4/7 (57%) of models trained on local institutional data performed inferiorly to the FL models. Model performance for local models was positively correlated with label agreement (between clinical and RSD labels, CC = 0.389, p=0.387), total number of plus cases (CC=0.759, p=0.047), overall training set size (CC=0.924, p=0.002).CONCLUSIONS: We show that a FL model trained performs comparably to a centralized model, confirming that FL may provide an effective, more feasible solution for inter-institutional learning. Smaller institutions benefit more from collaboration than larger institutions, showing the potential of FL for addressing disparities in resource access.

  View details for DOI 10.1016/j.oret.2022.02.015

  View details for PubMedID 35296449

• Artificial Intelligence for Retinopathy of Prematurity: Validation of a Vascular Severity Scale against International Expert Diagnosis. Ophthalmology Campbell, J. P., Chiang, M. F., Chen, J. S., Moshfeghi, D. M., Nudleman, E., Ruambivoonsuk, P., Cherwek, H., Cheung, C. Y., Singh, P., Kalpathy-Cramer, J., Ostmo, S., Eydelman, M., Chan, R. V., Capone, A. J., CCOI Executive Committee and the CCOI Retinopathy of Prematurity Workgroup 2022

  Abstract

  OBJECTIVE: To validate a vascular severity score as an appropriate output for artificial intelligence (AI) Software as a Medical Device (SaMD) for retinopathy of prematurity (ROP) through comparison with ordinal disease severity labels for stage and plus disease assigned by the International Classification of ROP, 3rd edition (ICROP3) committee.DESIGN: Validation study of an AI-based ROP vascular severity score Subjects, Participants, and/or Controls: 34 ROP experts from the ICROP3 committee.METHODS: Two separate datasets of 30 fundus photographs each for stage (0-5) and plus disease (plus, pre-plus, neither) were labeled by members of the ICROP3 committee using an open-source platform. Averaging these results produced a continuous label for plus (1-9) and stage (1-3) for each image. Experts were also asked to compare each image to each other in terms of relative severity for plus disease. Each image was also labelled with a vascular severity score from the Imaging and Informatics in ROP deep learning (i-ROP DL) system, which was compared with each grader's diagnostic labels for correlation, as well as the ophthalmoscopic diagnosis of stage.MAIN OUTCOME MEASURES: Weighted kappa and Pearson correlation coefficients (CC) were calculated between each pair of grader classification labels for stage and plus disease. The Elo algorithm was also used to convert pairwise comparisons for each expert into an ordered set of images from least to most severe.RESULTS: The mean weighted kappa and CC for all inter-observer pairs for plus disease image comparison was 0.67 and 0.88 respectively. The vascular severity score was found to be highly correlated with both the average plus disease classification (CC = 0.90, p < 0.001) and the ophthalmoscopic diagnosis of stage (p < 0.001 by ANOVA) among all experts.CONCLUSIONS: The ROP vascular severity score correlates well with the ICROP committee member's labels for plus disease and stage, which had significant inter-grader variability. Generation of a consensus for a validated scoring system for ROP SaMD can facilitate global innovation and regulatory authorization of these technologies.

  View details for DOI 10.1016/j.ophtha.2022.02.008

  View details for PubMedID 35157950

• The Effect of Eye Drop Technique Education in Patients With Glaucoma. Health communication Carpenter, D. M., Sayner, R., Blalock, S. J., Muir, K. W., Hartnett, M. E., Lawrence, S. D., Giangiacomo, A. L., Goldsmith, J. A., Tudor, G. E., Robin, A. L., Sleath, B. L. 2016; 31 (8): 1036-42

  Abstract

  Education about how to administer eye drops may improve a patient's ability to instill his or her eye drops correctly. Our objectives were to (a) document the methods providers use to educate glaucoma patients about eye drop technique; (b) determine whether eye drop technique education varies by provider and patient characteristics; and (c) evaluate whether education predicts improved patient technique. We conducted an 8-month longitudinal study of 279 glaucoma patients and 15 providers in which we recorded on videotape the content of glaucoma office visits at two time points (baseline and 4- to 6-week follow-up) and videotaped patient eye drop technique at three time points (baseline, 4- to 6-week follow-up, and 8-month follow-up). Mann-Whitney rank sum tests were used to determine whether education was associated with improved patient eye drop technique over time. Ninety-four patients (34%) received technique education at either visit; 31% received verbal education and 10% received a technique demonstration. Only 24 patients (47%) who were new to eye drops received technique education at the baseline visit. Patients who were new to drops at baseline (p = .008) and patients who asked a question about drops (p < .001) were more likely to receive technique education. Education was not associated with improved technique. Eye drop technique education occurs infrequently during glaucoma office visits. Future studies should compare the effectiveness of different educational methods, such as patient demonstration versus provider verbal instruction, to determine which method is best at improving patient eye drop technique.

  View details for DOI 10.1080/10410236.2015.1020263

  View details for PubMedID 26751938

• Communication Predicts Medication Self-Efficacy in Glaucoma Patients. Optometry and vision science : official publication of the American Academy of Optometry Carpenter, D. M., Blalock, S. J., Sayner, R., Muir, K. W., Robin, A. L., Hartnett, M. E., Giangiacomo, A. L., Tudor, G. E., Sleath, B. L. 2016; 93 (7): 731-7

  Abstract

  Medication self-efficacy, or patients' confidence that they can perform medication-related behaviors, is associated with better glaucoma medication adherence. Little is known about how to enhance glaucoma patients' medication self-efficacy. Our purpose is to examine whether patient-provider communication increases glaucoma patients' medication self-efficacy.During an 8-month cohort study of 279 glaucoma patients and 15 providers, two office visits were videotape-recorded, transcribed, and coded for six patient-provider communication behaviors. A validated scale was used at baseline and 8-month follow-up to assess patients' confidence in overcoming adherence barriers (adherence barriers self-efficacy) and carrying out tasks to use eye drops correctly (eye drop task self-efficacy). We ran two generalized estimating equations to examine whether more frequent patient-provider communication during office visits predicted increased patient adherence barriers self-efficacy and eye drop task self-efficacy at 8-month follow-up.For each additional topic providers educated about, patients reported an average increase of 0.35 in self-efficacy in overcoming adherence barriers (p < 0.001). Patients also reported an average increase of 1.01 points in eye drop task self-efficacy when providers asked about patients' views of glaucoma and its treatment versus not (p < 0.001). Patients who asked more medication questions (p < 0.001) and African-American patients (p < 0.05) reported lower adherence barriers self-efficacy by 0.30 and 2.15 points, respectively. Women had a 0.63 lower eye drop task self-efficacy than men (p < 0.05).When providers educate glaucoma patients and assess patient views about glaucoma and its treatment, patients report higher medication self-efficacy. Providers should be aware that patients who ask more medication questions may have less confidence in their ability to overcome barriers to adherence.

  View details for DOI 10.1097/OPX.0000000000000856

  View details for PubMedID 27003815

  View details for PubMedCentralID PMC4915983

• Exploring the influence of patient-provider communication on intraocular pressure in glaucoma patients PATIENT EDUCATION AND COUNSELING Carpenter, D. M., Tudor, G. E., Sayner, R., Muir, K. W., Robin, A. L., Blalock, S. J., Hartnett, M. E., Giangiacomo, A. L., Sleath, B. L. 2015; 98 (12): 1558-1567

  Abstract

  We examined whether six patient-provider communication behaviors directly affected the intraocular pressure (IOP) of glaucoma patients or whether patient medication adherence and eye drop technique mediated the relationship between self-efficacy, communication, and IOP.During an 8-month, longitudinal study of 279 glaucoma patients and 15 providers, two office visits were videotape-recorded, transcribed, and coded for six patient-provider communication behaviors. Medication adherence was measured electronically and IOP was extracted from medical records. We ran generalized estimating equations to examine the direct effects of communication on IOP and used bootstrapping to test whether medication adherence and eye drop technique mediated the effect of communication on IOP.Provider education about medication adherence (B=-0.50, p<0.05) and inclusion of patient input into the treatment plan (B=-0.35, p<0.05) predicted improved IOP. There was no evidence of significant mediation.The positive effects of provider education and provider inclusion of patient input in the treatment plan were not mediated by adherence and eye drop technique.Providers should educate glaucoma patients about the importance of medication adherence and include patient input into their treatment plan.

  View details for DOI 10.1016/j.pec.2015.07.001

  View details for Web of Science ID 000368332400011

  View details for PubMedCentralID PMC4703566

• Dexamethasone Intravitreal Implant in Patients with Macular Edema Related to Branch or Central Retinal Vein Occlusion OPHTHALMOLOGY Haller, J. A., Bandello, F., Belfort, R., Blumenkranz, M. S., Gillies, M., Heier, J., Loewenstein, A., Yoon, Y. H., Jiao, J., Li, X., Whitcup, S. M. 2011; 118 (12): 2453-2460

  Abstract

  To evaluate the safety and efficacy of 1 or 2 treatments with dexamethasone intravitreal implant (DEX implant) over 12 months in eyes with macular edema owing to branch or central retinal vein occlusion (BRVO or CRVO).Two identical, multicenter, prospective studies included a randomized, 6-month, double-masked, sham-controlled phase followed by a 6-month open-label extension.We included 1256 patients with vision loss owing to macular edema associated with BRVO or CRVO.At baseline, patients received DEX implant 0.7 mg (n = 421), DEX implant 0.35 mg (n = 412), or sham (n = 423) in the study eye. At day 180, patients could receive DEX implant 0.7 mg if best-corrected visual acuity (BCVA) was <84 letters or retinal thickness was >250 μm.The primary outcome for the open-label extension was safety; BCVA was also evaluated.At day 180, 997 patients received open-label DEX implant. Except for cataract, the incidence of ocular adverse events was similar in patients who received their first or second DEX implant. Over 12 months, cataract progression occurred in 90 of 302 phakic eyes (29.8%) that received 2 DEX implant 0.7 mg injections versus 5 of 88 sham-treated phakic eyes (5.7%); cataract surgery was performed in 4 of 302 (1.3%) and 1 of 88 (1.1%) eyes, respectively. In the group receiving two 0.7-mg DEX implants (n = 341), a ≥ 10-mmHg intraocular pressure (IOP) increase from baseline was observed in (12.6% after the first treatment, and 15.4% after the second). The IOP increases were usually transient and controlled with medication or observation; an additional 10.3% of patients initiated IOP-lowering medications after the second treatment. A ≥ 15-letter improvement in BCVA from baseline was achieved by 30% and 32% of patients 60 days after the first and second DEX implant, respectively.Among patients with macular edema owing to BRVO or CRVO, single and repeated treatment with DEX implant had a favorable safety profile over 12 months. In patients who qualified for and received 2 DEX implant injections, the efficacy and safety of the 2 implants were similar with the exception of cataract progression.Proprietary or commercial disclosure may be found after the references.

  View details for DOI 10.1016/j.ophtha.2011.05.014

  View details for Web of Science ID 000298138000022

• Randomized, Sham-Controlled Trial of Dexamethasone Intravitreal Implant in Patients with Macular Edema Due to Retinal Vein Occlusion OPHTHALMOLOGY Haller, J. A., Bandello, F., Belfort, R., Blumenkranz, M. S., Gillies, M., Heier, J., Loewenstein, A., Yoon, Y., Jacques, M., Jiao, J., Li, X., Whitcup, S. M. 2010; 117 (6): 1134-U164

  Abstract

  To evaluate the safety and efficacy of dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) compared with sham in eyes with vision loss due to macular edema (ME) associated with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).Two identical, multicenter, masked, randomized, 6-month, sham-controlled clinical trials (each of which included patients with BRVO and patients with CRVO).A total of 1267 patients with vision loss due to ME associated with BRVO or CRVO.A single treatment with DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham (n = 426).The primary outcome measure for the pooled data from the 2 studies was time to achieve a > or =15-letter improvement in best-corrected visual acuity (BCVA). Secondary end points included BCVA, central retinal thickness, and safety.After a single administration, the time to achieve a > or =15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham (P<0.001). The percentage of eyes with a > or =15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham at days 30 to 90 (P<0.001). The percentage of eyes with a > or =15-letter loss in BCVA was significantly lower in the DEX implant 0.7-mg group compared with sham at all follow-up visits (P< or =0.036). Improvement in mean BCVA was greater in both DEX implant groups compared with sham at all follow-up visits (P< or =0.006). Improvements in BCVA with DEX implant were seen in patients with BRVO and patients with CRVO, although the patterns of response differed. The percentage of DEX implant-treated eyes with intraocular pressure (IOP) of > or =25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. There was no significant between-group difference in the occurrence of cataract or cataract surgery.Dexamethasone intravitreal implant can both reduce the risk of vision loss and improve the speed and incidence of visual improvement in eyes with ME secondary to BRVO or CRVO and may be a useful therapeutic option for eyes with these conditions.

  View details for DOI 10.1016/j.ophtha.2010.03.032

  View details for Web of Science ID 000278224400008

  View details for PubMedID 20417567