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Shoshany TN, Chinn RN, Staffa SJ, Bishop K, Michalak S, Hunter DG. Identifying Characteristics Predictive of Lost-to-follow-up (LTFU) Status in Amblyopia. Am J Ophthalmol 2021;Abstract
PURPOSE: To identify demographic and disease-related characteristics predictive of LTFU status in amblyopia treatment and create a risk model for predicting LTFU status. DESIGN: Retrospective cohort study METHODS: Setting: Single center, ophthalmology department at Boston Children's Hospital (BCH). PATIENTS: 2037 patients treated for amblyopia at BCH between 2010-2014. OBSERVATION PROCEDURE: LTFU was defined as patients who did not return after initial visit, excluding those who came for second opinion. Multiple variables were tested for association with LTFU status. OUTCOME MEASURE: Odds ratio of LTFU risk associated with each variable. Multivariate logistic regression was used to create a risk score for predicting LTFU status. RESULTS: A large proportion of patients (23%) were LTFU after first visit. Older age, non-white race, lack of insurance, previous glasses or atropine treatment, and longer requested follow-up intervals were independent predictors of LTFU status. A multivariable risk score was created to predict probability of LTFU (AUC 0.68). CONCLUSIONS: Our comprehensive amblyopia database allows us to predict which patients are more likely to be LTFU after baseline visit, and develop strategies to mitigate these effects. These findings may help with practice efficiency and improve patient outcomes in the future by transitioning these analyses to an electronic medical record that could be programmed to provide continually updated decision support for individual patients based on large datasets.
Glassman AR, Beaulieu WT, Maguire MG, Antoszyk AN, Chow CC, Elman MJ, Jampol LM, Salehi-Had H, Sun JK, Sun JK. Visual Acuity, Vitreous Hemorrhage, and Other Ocular Outcomes After Vitrectomy vs Aflibercept for Vitreous Hemorrhage Due to Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol 2021;139(7):725-733.Abstract
Importance: Although there were no differences in mean visual acuity (VA) over 24 weeks after vitrectomy with panretinal photocoagulation (PRP) vs aflibercept in a randomized clinical trial among eyes with vitreous hemorrhage due to proliferative diabetic retinopathy (PDR), post hoc analyses may influence treatment choices. Objective: To compare exploratory outcomes between treatment groups that may affect treatment choices for patients with vitreous hemorrhage due to PDR. Design, Setting, and Participants: This post hoc analysis of a randomized clinical trial conducted at 39 DRCR Retina Network sites included adults with vision loss due to PDR-related vitreous hemorrhage for whom vitrectomy was considered. Data were collected from November 2016 to January 2020. Interventions: Random assignment to 4 monthly injections of aflibercept vs vitrectomy with PRP. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol-specific criteria. Main Outcomes and Measures: Visual acuity area under the curve (adjusted for baseline VA) and clearance of vitreous hemorrhage. Results: A total of 205 eyes were included in the analysis (115 male [56%] and 90 [44%] female participants; mean [SD] age, 57 [11] years). Among 89 eyes with a baseline VA of 20/32 to 20/160 (47 receiving aflibercept, including 4 [9%] that had undergone vitrectomy; 42 undergoing vitrectomy, including 3 [7%] that had received aflibercept), the adjusted mean difference in VA letter score over 24 weeks between the aflibercept and vitrectomy groups was -4.3 (95% CI, -10.6 to 1.9) compared with -16.7 (95% CI, -24.4 to -9.1) among 59 eyes with baseline VA worse than 20/800 (P = .02 for interaction; 26 in the aflibercept group, including 6 [23%] that had undergone vitrectomy; 33 in the vitrectomy group, including 8 [24%] that had received aflibercept). In the full cohort, the median time to clearance of the initial vitreous hemorrhage was 36 (interquartile range [IQR], 24-52) weeks in the aflibercept group vs 4 (IQR, 4-4) weeks in the vitrectomy group (difference, 32 [95% CI, 20-32] weeks; P < .001). Conclusions and Relevance: Both initial aflibercept and vitrectomy with PRP are viable treatment approaches for PDR-related vitreous hemorrhage. Although this study did not find a significant difference between groups in the primary outcome of mean VA over 24 weeks of follow-up, eyes receiving initial vitrectomy with PRP had faster recovery of vision over 24 weeks when baseline VA was worse than 20/800 and faster vitreous hemorrhage clearance. Approximately one-third of the eyes in each group received the alternative treatment (aflibercept or vitrectomy with PRP). These factors may influence treatment decisions for patients initiating therapy for PDR-related vitreous hemorrhage. Trial Registration: ClinicalTrials.gov Identifier: NCT02858076.
Yuan A, Ma K, Sharifi S, Pineda R. Biomechanical testing of flanged polypropylene sutures in scleral fixation. Am J Ophthalmol 2021;Abstract
OBJECTIVE: To optimize the flanged belt-loop technique of scleral fixation through biomechanical testing and report clinical outcomes of resultant modifications. DESIGN: Experimental study. METHODS: The force to disinsert flanged polypropylene suture from human cadaveric sclera was assessed using a tensile testing machine and compared to the breaking strengths of 9-0 and 10-0 polypropylene. The effects of modifying suture gauge (5-0, 6-0, 7-0 or 8-0), amount of suture cauterized (0.5 or 1.0mm), and sclerotomy size (27-, 30-, 32-, 33-gauge) were investigated. Belt-loop intrascleral fixation using 6-0 and 7-0 polypropylene with 30- and 32-gauge needles respectively was performed in 5 patients. MAIN OUTCOME MEASURES: Flanged suture disinsertion force in cadaveric sclera. RESULTS: The average force to disinsert a flange created by melting 1.0mm of 5-0, 6-0, 7-0 and 8-0 polypropylene suture from human cadaveric sclera via 27-, 30-, 32- and 33-gauge needle sclerotomies was 3.0 ± 0.5N, 2.1 ± 0.3N, 0.9 ± 0.2N and 0.4 ± 0.1N respectively. The disinsertion forces for flanges formed by melting 0.5mm of the same gauges were 72-79% lower (p < 0.001). In comparison, the breaking strengths of 9-0 and 10-0 polypropylene were 1.0 ± 0.2N and 0.5 ± 0.0N. Belt-loop fixation using 6-0 and 7-0 polypropylene with 30- and 32-gauge sclerotomies demonstrated good outcomes at 6 months. CONCLUSIONS: The flanged belt-loop technique is a biomechanically sound method of scleral fixation using 1.0mm flanges of 5-0 to 7-0 polypropylene paired with 27-, 30- and 32- gauge sclerotomies. In contrast, 8-0 polypropylene and 0.5 mm flanges of any suture gauge will likely be unstable with this technique.
Singh RB, Liu L, Anchouche S, Yung A, Mittal SK, Blanco T, Dohlman TH, Yin J, Dana R. Ocular redness - I: Etiology, pathogenesis, and assessment of conjunctival hyperemia. Ocul Surf 2021;21:134-144.Abstract
The translucent appearance of the conjunctiva allows for immediate visualization of changes in the circulation of the conjunctival microvasculature consisting of extensive branching of superficial and deep arterial systems and corresponding drainage pathways, and the translucent appearance of the conjunctiva allows for immediate visualization of changes in the circulation. Conjunctival hyperemia is caused by a pathological vasodilatory response of the microvasculature in response to inflammation due to a myriad of infectious and non-infectious etiologies. It is one of the most common contributors of ocular complaints that prompts visits to medical centers. Our understanding of these neurogenic and immune-mediated pathways has progressed over time and has played a critical role in developing targeted novel therapies. Due to a multitude of underlying etiologies, patients must be accurately diagnosed for efficacious management of conjunctival hyperemia. The diagnostic techniques used for the grading of conjunctival hyperemia have also evolved from descriptive and subjective grading scales to more reliable computer-based objective grading scales.
Lonial S, Nooka AK, Thulasi P, Badros AZ, Jeng BH, Callander NS, Potter HA, Sborov D, Zaugg BE, Popat R, Esposti SD, Byrne J, Opalinska J, Baron J, Piontek T, Gupta I, Dana R, Farooq AV, Colby K, Jakubowiak A. Management of belantamab mafodotin-associated corneal events in patients with relapsed or refractory multiple myeloma (RRMM). Blood Cancer J 2021;11(5):103.Abstract
Belantamab mafodotin (belamaf) demonstrated deep and durable responses in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM) in DREAMM-2 (NCT03525678). Corneal events, specifically keratopathy (including superficial punctate keratopathy and/or microcyst-like epithelial changes (MECs), eye examination findings with/without symptoms), were common, consistent with reports from other antibody-drug conjugates. Given the novel nature of corneal events in RRMM management, guidelines are required for their prompt identification and appropriate management. Eye examination findings from DREAMM-2 and insights from hematology/oncology investigators and ophthalmologists, including corneal specialists, were collated and used to develop corneal event management guidelines. The following recommendations were formulated: close collaboration among hematologist/oncologists and eye care professionals is needed, in part, to provide optimal care in relation to the belamaf benefit-risk profile. Patients receiving belamaf should undergo eye examinations before and during every treatment cycle and promptly upon worsening of symptoms. Severity of corneal events should be determined based on corneal examination findings and changes in best-corrected visual acuity. Treatment decisions, including dose modifications, should be based on the most severe finding present. These guidelines are recommended for the assessment and management of belamaf-associated ocular events to help mitigate ocular risk and enable patients to continue to experience a clinical benefit with belamaf.
Godfrey D, Torres A, Heidary G, Zahoor H, Lee A, Berry G, Engle E. A 7-year old female with arthrogryposis multiplex congenita, Duane retraction syndrome, and Marcus Gunn phenomenon due to a ZC4H2 gene mutation: a clinical presentation of the Wieacker-Wolff syndrome. Ophthalmic Genet 2021;42(5):612-614.Abstract
Background: Duane retraction syndrome and arthrogryposis multiplex congenita have an incidence of approximately 1:1500-1:3000 live births. However, the association of these two entities with a Marcus-Gunn might be a rare and, until now, under-recognized clinical presentation of the Wieacker-Wolff Syndrome.Patient and methods: We report a 7-year-old female with dysmorphic features, global developmental delay, arthrogryposis multiplex congenita (AMC), Duane retraction syndrome (DRS), and unilateral Marcus Gunn jaw winking.Results: Whole Exome Sequencing showed a de novo premature stop codon in ZC4H2. Extensive genetic and metabolic work was negative otherwise and Brain MRI showed delayed non-specific myelination abnormalities. She continues to have significant delays but does not have regression, seizures or other neurological complications. She has required a multidisciplinary approach for the management of her multiple contractures.Conclusion: This case confirms ZC4H2 as a cause of syndromic DRS and extends the ZC4H2 phenotype to include Marcus Gunn jaw winking.
Olson HE, Costantini JG, Swanson LC, Kaufmann WE, Benke TA, Fulton AB, Hansen R, Poduri A, Heidary G. Cerebral visual impairment in CDKL5 deficiency disorder: vision as an outcome measure. Dev Med Child Neurol 2021;63(11):1308-1315.Abstract
AIM: To characterize the neuro-ophthalmological phenotype of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) and assess visual acuity as a reproducible, quantitative outcome measure. METHOD: We retrospectively analyzed clinical data from patients with CDD. Complete neuro-ophthalmological assessments, including visual acuity, were evaluated. RESULTS: Of 26 patients (22 females, four males; median age 4y, interquartile range 2y 1mo-7y 10mo), cerebral visual impairment (CVI), defined as visual dysfunction in the absence of ocular or anterior visual pathway abnormalities, was diagnosed in all those over 2 years of age. Ophthalmological examinations revealed nystagmus in 10 patients and strabismus in 24 patients. Visual acuity was measured in 24 patients, by preferential looking in all and by sweep visual evoked potential in 13. Visual acuities were lower than age expectations and demonstrated improvement in the first 3 years. Adjusting for age and sex, average preferential looking visual acuity after 2 years of age was higher in patients with intact mobility than in those who were non-mobile. INTERPRETATION: CVI was observed in patients with CDD. Visual acuity improved over time and correlated with mobility. Visual acuity, as a quantifiable measure of visual function, should be considered as an outcome measure in pre-clinical and clinical studies for CDD. What this paper adds Cerebral visual impairment is highly prevalent in cyclin-dependent kinase-like 5 deficiency disorder (CDD). Visual acuity is a measurable quantitative outcome measure in CDD. Visual acuity in CDD correlates with gross motor ability.
E J-Y, Mihailovic A, Garzon C, Schrack JA, Li T, West SK, Friedman DS, Gitlin LN, Ramulu PY. Importance and severity dependence of physical activity by GPS-tracked location in glaucoma patients: GPS-tracked physical activity in glaucoma. Am J Ophthalmol 2021;Abstract
PURPOSE: To quantify the association of visual field (VF) damage on physical activity away-from-home, per away-from-home excursion, and at home. DESIGN: Prospective cohort study. METHODS: Among 229 participants with glaucoma or suspected glaucoma, severity of VF damage was defined as average sensitivity within the integrated VF (IVF). Participants wore accelerometers and GPS trackers for seven days to measure physical activity and characterize activity location. Multivariable negative binomial regressions were used to test whether away-from-home activity per day, physical activity per away-from-home excursion, and at home activity per day varied by severity of VF damage. RESULTS: Each 5-dB decrement in IVF sensitivity was associated with a lower amount of away-from-home activities per day [18% less Moderate & Vigorous Physical Activity (MVPA) minutes/day, 95% CI, 0.69 to 0.97], and physical activities per away-from-home excursion (20% less MVPA minutes/excursion, 95% CI, 0.65, 0.98). Similar findings were noted for other away-from-home activity measures (including active minutes/steps per day, or active minutes/steps per excursion). However, worse IVF sensitivity was not associated with measures of at home activities (MVPA minutes/day, active minutes/day, and steps/day), time spent at or away from home, or excursions/week (p>0.1 for all). CONCLUSIONS: Restriction of physical activity in more severe glaucoma patients results mostly from activity restriction outside home environment. These findings highlight the importance of maintaining a safe home environment (where activity is less restricted) and increasing confidence to perform activity, particular high intensity activity, when leaving the home amongst patients with glaucoma.
Ciociola EC, Kavitha S, Sengupta S, Wiggs JL, Kader MA, Raman GV, Rajendrababu S, Ramulu PY, Venkatesh R, Zebardast N. The Heritability of Primary Angle Closure Anatomic Traits and Predictors of Angle Closure in South Indian Siblings. Am J Ophthalmol 2021;Abstract
PURPOSE: To estimate the heritability of ocular biometric and anterior chamber morphologic parameters and to determine predictors of angle closure concordance in South Indian probands with angle closure and their siblings. DESIGN: Prospective observational cohort study. METHODS: Subjects received a standardized ophthalmic examination, A-scan ultrasonography, pachymetry, and anterior segment optical coherence tomography (ASOCT) imaging. Heritability was calculated using residual correlation coefficients adjusted for age, sex, and home setting. Concordant siblings pairs were defined as both proband and sibling with angle closure. Predictors of angle closure concordance among siblings were calculated using multivariable logistic regression models. RESULTS: 345 sibling pairs participated. All anterior chamber parameters were highly heritable (p<0.001 for all). Similarly, all iris parameters, axial length, lens thickness (LT), central corneal thickness, anterior lens curvature, lens vault (LV), spherical equivalent, and intraocular pressure were moderately to highly heritable (p<0.004 for all). LV and LT were more heritable among concordant siblings (p<0.05 for both). In contrast, ASOCT angle parameters had statistically insignificant heritability estimates. In multivariable analyses, siblings older than their probands were more likely to be concordant for angle closure (OR=1.05 (95% CI 1.01, 1.09), p=0.02) and siblings with deeper anterior chamber depths (ACD) compared to their proband were less likely to be concordant for angle closure (OR=0.74 (95% CI 0.64, 0.86), p<0.001). CONCLUSIONS: Iris, anterior chamber, and lens parameters may be heritable while angle parameters were not. LT and LV may play important roles in the pathogenesis of angle closure. Siblings who are older or have a shallower ACD may need more careful disease monitoring.
Simpson FC, McTiernan CD, Islam MM, Buznyk O, Lewis PN, Meek KM, Haagdorens M, Audiger C, Lesage S, Gueriot F-X, Brunette I, Robert M-C, Olsen D, Koivusalo L, Liszka A, Fagerholm P, Gonzalez-Andrades M, Griffith M. Collagen analogs with phosphorylcholine are inflammation-suppressing scaffolds for corneal regeneration from alkali burns in mini-pigs. Commun Biol 2021;4(1):608.Abstract
The long-term survival of biomaterial implants is often hampered by surgery-induced inflammation that can lead to graft failure. Considering that most corneas receiving grafts are either pathological or inflamed before implantation, the risk of rejection is heightened. Here, we show that bioengineered, fully synthetic, and robust corneal implants can be manufactured from a collagen analog (collagen-like peptide-polyethylene glycol hybrid, CLP-PEG) and inflammation-suppressing polymeric 2-methacryloyloxyethyl phosphorylcholine (MPC) when stabilized with the triazine-based crosslinker 4-(4,6-Dimethoxy-1,3,5-triazin-2-yl)-4-methylmorpholinium chloride. The resulting CLP-PEG-MPC implants led to reduced corneal swelling, haze, and neovascularization in comparison to CLP-PEG only implants when grafted into a mini-pig cornea alkali burn model of inflammation over 12 months. Implants incorporating MPC allowed for faster nerve regeneration and recovery of corneal sensation. CLP-PEG-MPC implants appear to be at a more advanced stage of regeneration than the CLP-PEG only implants, as evidenced by the presence of higher amounts of cornea-specific type V collagen, and a corresponding decrease in the presence of extracellular vesicles and exosomes in the corneal stroma, in keeping with the amounts present in healthy, unoperated corneas.
Luo ZK, Domenech-Estarellas EA, Han A, Lee D, Khatri R, Wahl JL, Cutler C, Armand P, Antin JH, Koreth J, Gooptu M, Alyea EP, Soiffer RJ, Ho VT. Efficacy and Safety of 1% Progesterone Gel to the Forehead for Ocular Chronic Graft-versus-Host Disease. Transplant Cell Ther 2021;27(5):433.e1-433.e8.Abstract
There is no Food and Drug Administration-approved treatments for ocular chronic graft-versus-host disease (oGVHD) to date, and current therapeutic options are limited. Forehead application of 1% progesterone gel provides corneal antinociception in preclinical models, suggesting it may be useful in alleviating ocular irritations. This study was conducted to evaluate the efficacy and safety of 1% progesterone gel in treating moderate to severe symptomatic oGVHD. Thirty-three patients with oGVHD following allogeneic stem cell transplantation were enrolled in this single-center, sponsor-initiated, prospective exploratory randomized double-masked placebo-controlled phase II clinical trial. The inclusion criteria included a National Institutes of Health consensus score of ≥2, moderate to severe ocular discomfort level, and receipt of a stable immunosuppression regimen. Twenty-one of the 22 patients in the progesterone arm and all 11 patients in the placebo arm completed the course of twice-daily forehead drug application for 10 weeks. The changes from baseline of self-reported ocular symptom scores and physician-recorded cornea fluorescein staining scores were analyzed using mixed-model repeated-measures regression model in an intention-to-treat population. The 33 patients included 12 women and 21 men, with a median age of 66 years (range, 24 to 75 years). At 10 weeks, there was a significant reduction in ocular symptoms from baseline in the progesterone group compared with the placebo group in symptom frequency (-30.7 versus -2.2; P < .001) and severity (-19.8 versus +1.6; P = .005). At 10 weeks, there was also greater reduction of cornea fluorescein staining centrally (-1.2 versus +.1; P = .001) and inferiorly (-1.4 versus -0.2; P = .005). No difference was noted in superior cornea staining. There were no severe adverse events in the progesterone group. Forehead application of 1% progesterone gel significantly improved ocular signs and symptoms within 10 weeks. It appears to be a safe and effective new therapy for oGVHD, and a novel mechanism for neuroaxis drug delivery. A multicenter phase III clinical trial is planned for further validation.
Kanu LN, Ciolino JB. Nerve Growth Factor as an Ocular Therapy: Applications, Challenges, and Future Directions. Semin Ophthalmol 2021;36(4):224-231.Abstract
Nerve growth factor (NGF), the prototypical neurotrophin first discovered in the 1950s, has recently garnered increased interest as a therapeutic agent promoting neuronal health and regeneration. After gaining orphan drug status within the last decade, NGF-related research and drug development has accelerated. The purpose of this article is to review the preclinical and clinical evidence of NGF in various applications, including central and peripheral nervous system, skin, and ophthalmic disorders. We focus on the ophthalmic applications including not only the FDA-approved indication of neurotrophic keratitis but also retinal disease and glaucoma. NGF represents a promising therapy whose therapeutic profile is evolving. The challenges related to this therapy are reviewed, along with possible solutions and future directions.
Celebi ARC, Park EA, Verticchio Vercellin AC, Tsikata E, Lee R, Shieh E, Antar H, Freeman M, Zhang J, Que C, Simavli H, McClurkin M, Guo R, Elze T, de Boer JF, Chen TC. Structure-Function Mapping Using a Three-Dimensional Neuroretinal Rim Parameter Derived From Spectral Domain Optical Coherence Tomography Volume Scans. Transl Vis Sci Technol 2021;10(6):28.Abstract
Purpose: To assess the structure-function relationship in glaucoma using Humphrey visual field (HVF) perimetry and a three-dimensional neuroretinal rim parameter derived from spectral domain optical coherence tomography (SD-OCT) volume scans. Methods: Structure-function correlation was analyzed globally and regionally (four quadrants and four sectors). Structural data included peripapillary retinal nerve fiber layer (RNFL) thickness and minimum distance band (MDB) neuroretinal rim thickness, defined as the shortest distance between the inner cup surface and the outer retinal pigment epithelium/Bruch's membrane complex. Logarithmic regression analyses were performed and Pearson correlation coefficients determined to assess relationship strength. Results: The study consisted of 102 open-angle glaucoma patients and 58 healthy subjects. The Pearson correlation coefficient for global MDB thickness (R = 0.585) was higher than for global RNFL thickness (R = 0.492), but the difference was not statistically significant (P = 0.18). The correlation coefficients for regional MDB thicknesses and corresponding HVF sensitivities were higher than those for regional RNFL thicknesses and HVF in six out of eight regions (P = 0.08 to 0.47). In the remaining two out of eight regions, the correlation coefficients were higher for RNFL thickness than for MDB thickness (P = 0.15 to 0.20). Conclusions: Three-dimensional MDB neuroretinal rim thickness relates to visual function as strongly as the most commonly used SD-OCT parameter for glaucoma, two-dimensional peripapillary RNFL thickness. Translational Relevance: This paper illustrates the potential for 3D OCT algorithms to improve in vivo imaging in glaucoma.
Oke I, Vanderveen D. Machine Learning Applications in Pediatric Ophthalmology. Semin Ophthalmol 2021;36(4):210-217.Abstract
Purpose : To describe emerging applications of machine learning (ML) in pediatric ophthalmology with an emphasis on the diagnosis and treatment of disorders affecting visual development. Methods : Literature review of studies applying ML algorithms to problems in pediatric ophthalmology. Results : At present, the ML literature emphasizes applications in retinopathy of prematurity. However, there are increasing efforts to apply ML techniques in the diagnosis of amblyogenic conditions such as pediatric cataracts, strabismus, and high refractive error. Conclusions : A greater understanding of the principles governing ML will enable pediatric eye care providers to apply the methodology to unexplored challenges within the subspecialty.
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