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Evaluation of Shared Genetic Susceptibility to High and Low Myopia and Hyperopia
J. Willem L. Tideman, MD, PhD; Olavi P?rssinen, MD, PhD; Annechien E. G. Haarman, MD; et al.
doi : 10.1001/jamaophthalmol.2021.0497
JAMA Ophthalmol. 2021;139(6):601-609
Importance Uncertainty currently exists about whether the same genetic variants are associated with susceptibility to low myopia (LM) and high myopia (HM) and to myopia and hyperopia. Addressing this question is fundamental to understanding the genetics of refractive error and has clinical relevance for genotype-based prediction of children at risk for HM and for identification of new therapeutic targets.
Cardiovascular Adverse Events With Intravitreal Anti–Vascular Endothelial Growth Factor DrugsA Systematic Review and Meta-analysis of Randomized Clinical Trials
Nadège Ngo Ntjam, MSc; Marie Thulliez, MD; Gilles Paintaud, MD, PhD; et al.
doi : 10.1001/jamaophthalmol.2021.0640
JAMA Ophthalmol. 2021;139(6):610-619
Importance Systemic safety of intravitreal anti-vascular endothelial growth factor (anti-VEGF) is a matter of debate and regular updates are necessary.
Postoperative Photoreceptor Integrity Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Retinal Detachment RepairA Post Hoc Optical Coherence Tomography Analysis From the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial
Rajeev H. Muni, MD; Tina Felfeli, MD; Srinivas R. Sadda, MD; et al.
doi : 10.1001/jamaophthalmol.2021.0803
JAMA Ophthalmol. 2021;139(6):620-627
Importance Pneumatic retinopexy (PnR) is associated with superior visual acuity and reduced vertical metamorphopsia compared with pars plana vitrectomy (PPV) for primary rhegmatogenous retinal detachment (RRD). It is important to determine postoperative photoreceptor integrity with both surgical techniques.
Understanding Visual Acuity Outcomes After Retinal Detachment Repair by Assessing Photoreceptor Integrity on Spectral-Domain Optical Coherence Tomography
M?rten E. Brelén, BMBCh, PhD1; Carol Y. Cheung, PhD1
doi : 10.1001/jamaophthalmol.2021.0818
JAMA Ophthalmol. 2021;139(6):627-628
The annual incidence of rhegmatogenous retinal detachment is approximately 18 to 22 per 100?000 population1,2 and reported techniques for reattaching the retina include pneumatic retinopexy (PnR), scleral buckle, and pars plana vitrectomy (PPV). Recently, it has become increasingly common to repair a retinal detachment using vitrectomy and gas, given the higher anatomical success rate of this procedure. However, the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) showed that even though the anatomical success of PnR is lower than that of PPV, visual acuity outcomes were better and rates of postoperative metamorphopsia were lower in patients treated with PnR.3 It is important to note that long-acting gas tamponade (perfluoropropane) was used in 33 of 88 individuals (38%) in the PPV arm only. This difference could have influenced the anatomic success rates in favor of the PPV group with enhanced cataract formation in the PPV arm, which in turn could have influenced the visual acuity outcomes in favor of the PnR group. To understand further factors in the PnR arm that may have been associated with better functional outcomes, the study by Muni et al4 investigated the microstructural integrity of the outer retina on optical coherence tomography (OCT) between PnR and PPV groups.The results show a better preservation of the ellipsoid zone and external limiting membrane in the PnR group vs the PPV group, which, although not proving a causal relationship, has some biologic rationale to account for better functional outcomes when performing a PnR. Of note, it would be interesting to have further explorations by Muni et al4 to see if there were any confounding associations between use of perfluoropropane in the PPV group and worse microstructural integrity of the outer retina on OCT.
Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020
Sean T. Berkowitz, BS; Sylvia L. Groth, MD; Sapna Gangaputra, MD, MPH; et al.
doi : 10.1001/jamaophthalmol.2021.0857
JAMA Ophthalmol. 2021;139(6):629-637
Importance Diverse, representative enrollment in pivotal clinical trials is vital to sufficiently power subgroup analyses and ensure equity and validity of trial results.
Critical Importance of Diversity and Inclusion in Medical Product Development
P?ivi H. Miskala, MSPH, PhD1; Senaka A. Peter, MPH1
doi : 10.1001/jamaophthalmol.2021.0855
JAMA Ophthalmol. 2021;139(6):637-638
In this issue of JAMA Ophthalmology, Berkowitz et al1 present the racial and ethnic distribution of participants enrolled in clinical trials that led to US Food and Drug Administration (FDA) ophthalmology product approvals from 2000 to 2020 compared with the expected disease prevalence and racial/ethnic distribution in the US population. The authors reported that there has been a meaningful improvement in the enrollment of Asian, Hispanic or Latinx, and Black participants over the reported time frame, but their analysis suggests that underrepresentation of these patient populations in pivotal clinical trials persists. Similar findings of underrepresentation of racial and ethnic participants in ophthalmology trials of new molecular entities have also been reported by Birnbaum.2 This is emblematic of the disparity identified across clinical trials in various therapeutic areas as noted by Berkowitz et al.1 According to the US Census, the US will become a more racially and ethnically pluralistic society with less than 50% of the US population projected to be non-Hispanic White by 2044.3 If clinical trials continue to lack representation of diverse patient populations, the robustness and generalizability of the research findings to those populations may be limited.
Naturalistic Driving Techniques and Association of Visual Risk Factors With At-Fault Crashes and Near Crashes by Older Drivers With Vision Impairment
Thomas A. Swain, MPH; Gerald McGwin Jr, PhD; Joanne M. Wood, PhD; et al.
doi : 10.1001/jamaophthalmol.2021.0862
JAMA Ophthalmol. 2021;139(6):639-645
Importance Government motor vehicle crash reports used in the study of driver safety can be biased and incomplete. Naturalistic driving methods using in-vehicle instrumentation have been developed in recent years to objectively measure crashes and near crashes as they occur on the road using video and vehicle kinematic data.
Risk Factors for Crash Events
Sheila K. West, PhD1
doi : 10.1001/jamaophthalmol.2021.0856
JAMA Ophthalmol. 2021;139(6):645-646
AAA (Automobile Association of America) could just as easily stand for America’s Addiction to the Automobile. As a result of US dependence on automobiles, many urban and rural areas have poor to absent transportation infrastructure, and alternatives to driving a car are often expensive and inconvenient if they are present at all. For most of us, driving a car is a key to independence. Going back to prepandemic days, activities such as socializing, shopping, vacations, and others often involved a car as the mode of transportation. In the face of this dependency, teenagers are quick to want driving privileges and most people are understandably reluctant to relinquish driving even in the face of safety concerns.
Visual Outcomes and Complications After Lensectomy for Traumatic Cataract in Children
Writing Committee for the Pediatric Eye Disease Investigator Group (PEDIG)
doi : 10.1001/jamaophthalmol.2021.0980
JAMA Ophthalmol. 2021;139(6):647-653
Importance The Pediatric Eye Disease Investigator Group Cataract Registry provides a multicenter assessment of visual outcomes and complications after lensectomy for traumatic pediatric cataract.
Reevaluating the Association of Sex With ABCA4 Alleles in Patients With Stargardt Disease
Winston Lee, MA; Jana Zernant, PhD; Takayuki Nagasaki, PhD; et al.
doi : 10.1001/jamaophthalmol.2021.0460
JAMA Ophthalmol. 2021;139(6):654-657
Importance Probing differences in disease prevalence between sexes is challenging, especially in mendelian diseases. Independent replication of any association study is warranted.
Clinical Utility of Antiretinal Antibody Testing
John J. Chen, MD, PhD; Andrew McKeon, MB, BCh, MD; Tammy M. Greenwood, MS, MHA; et al.
doi : 10.1001/jamaophthalmol.2021.0651
JAMA Ophthalmol. 2021;139(6):658-662
Importance The clinical utility of most antiretinal antibodies (retina antibodies) currently available for testing remains unclear and unproven. Despite this, the presence of retinal antibodies is included in current diagnostic autoimmune retinopathy criteria.
Changes in the Optic Nerve Head and Choroid Over 1 Year of Spaceflight
Brandon R. Macias, PhD; Connor R. Ferguson, MS; Nimesh Patel, OD, PhD; et al.
doi : 10.1001/jamaophthalmol.2021.0931
JAMA Ophthalmol. 2021;139(6):663-667
Importance While 6-month data are available regarding spaceflight-associated neuro-ocular syndrome, manned missions for 1 year and beyond are planned, warranting evaluation for spaceflight-associated neuro-ocular syndrome beyond 6 months.
Salt-and-Pepper Retinopathy in a Woman With Hearing Loss
Benjamin I. Meyer, BS; Nieraj Jain, MD
doi : 10.1001/jamaophthalmol.2020.4624
JAMA Ophthalmol. 2021;139(6):668-669
A 58-year-old woman with interstitial cystitis presented for pentosan polysulfate (Elmiron) maculopathy screening. She reported no visual symptoms or ocular history, and routine eye examination results 6 months prior were reportedly normal. She was diagnosed with interstitial cystitis in 2004 and had been taking pentosan polysulfate, 100 mg twice daily, for 4½ years for a cumulative dose of 324 g. Her medical history was otherwise significant for moderate bilateral hearing loss detected in early childhood and type 2 diabetes, hyperlipidemia, and hypothyroidism treated with a therapeutic regimen of metformin, pravastatin, and levothyroxine supplementation, respectively.
A Growing Conjunctival Lesion in an Otherwise Healthy Patient
Sarah Schimansky, MB, BCh BAO; John Mitchard, MBBS(Lond), BSc, MPH; Jonathan E. Boulton, MBBS
doi : 10.1001/jamaophthalmol.2020.4628
JAMA Ophthalmol. 2021;139(6):670-671
A 73-year-old man was referred to our service for assessment of a slow-growing conjunctival lesion in the left eye. He had first noticed left eye discomfort and a fullness of the left lower eyelid 3 months previously. He denied any vision or systemic symptoms. His ophthalmic history was noncontributory. The patient’s medical history was notable only for prostate carcinoma, which was treated with radiotherapy 12 years ago. On examination, his visual acuities were 20/25 OU. Slitlamp examination of the anterior segment revealed diffuse yellow-pink polypoidal papules affecting the inferior fornix and inferior palpebral conjunctiva of the left eye (Figure 1A). The upper palpebral conjunctiva in the left eye had a velvety yellow appearance (Figure 1B). The remainder of the examination of both eyes was unremarkable. Initial investigations, including a complete blood cell count, urinalysis, and measurement of inflammatory markers, kidney function, and prostate-specific antigen level, were within normal limits. Serum electrophoresis showed raised monoclonal IgM bands (7.25 g/L; reference range, 0.50-2.00 g/L) with a ?/? light-chain ratio of 2.92 (reference range, 0.260-1.65).
An Echodense Choroidal Lesion in an Elderly Woman
Richard R. Pacheco, BA; Antonio Yaghy, MD; Carol L. Shields, MD
doi : 10.1001/jamaophthalmol.2020.4642
JAMA Ophthalmol. 2021;139(6):672-673
An 89-year-old asymptomatic woman presented to a new eye care professional for a routine examination. Examination findings showed a large choroidal mass in the left eye suspicious for a malignant neoplasm. The patient’s ocular history showed a cataract surgical procedure, YAG capsulotomy, and subsequent repair of retinal detachment with scleral buckle and pneumatic retinopexy in the left eye approximately 30 years earlier. Ophthalmoscopic examination results of the left eye revealed a peripheral retinal atrophy from previous cryotherapy treatment. A large choroidal mass was observed in the inferotemporal region. The patient was referred for further evaluation of the mass, which was suspected to represent choroidal melanoma.
Intermittent Esotropia in an Adult
Michael C. Brodsky, MD
doi : 10.1001/jamaophthalmol.2020.4929
JAMA Ophthalmol. 2021;139(6):674-675
A 33-year-old woman was referred for evaluation of intermittent esotropia. When playing video games at a distance or when reading, she developed oscillopsia with eyestrain and noted that her right eye turned up and in. She had undergone strabismus surgery for crossed eyes as a young child and more recently had laser in situ keratomileusis performed. She was medically healthy and neurodevelopmentally normal but had been born 4½ weeks premature. There was no family history of strabismus, and she denied diplopia.
A Dislocated Crystalline Lens in a Patient With Marfan Syndrome
Thomas Meirick, MD; Dong Yang, MD; Michele D. Lee, MD
doi : 10.1001/jamaophthalmol.2021.1533
JAMA Ophthalmol. 2021;139(6):e211533
A 46-year-old woman with Marfan syndrome presented with left crystalline lens dislocation due to zonular insufficiency. Her natural lenses had been noted to be partially subluxated when she was an infant, with spontaneous complete dislocation of her left lens over time. Her presenting visual acuity was 20/30 OU with aphakic spectacles. Her intraocular pressure levels were 26 mm Hg OD and 30 mm Hg OS. She underwent pars plana vitrectomy, lensectomy, and insertion of a scleral-fixated intraocular lens in the left eye. And intraoperative photograph (Figure) shows the patient’s dislocated native intraocular lens resting on the retina.
Corneal Crystals as an Initiating Factor for a Systemic Bone Marrow Transplant
Kelly Miller, MD; Joseph Iuorno, MD; Natario L. Couser, MD, MS
doi : 10.1001/jamaophthalmol.2021.1539
JAMA Ophthalmol. 2021;139(6):e211539
A 59-year-old woman presented with bilateral corneal crystals (Figure, A). Ocular cystinosis was suspected; however, there were no pathogenic variants in the cystinosin, lysosomal cystine transporter (CTNS) gene. No underlying causative mechanism raising concern for systemic disease was revealed by a kidney biopsy. A positive M spike led to a bone marrow biopsy, which showed 20% plasma cell neoplasm and confirmed a diagnosis of multiple myeloma. A corneal biopsy was performed prior to further organ system evaluation, and immunohistochemical staining returned positive results for ? light chains (Figure, B). No other organ systems were involved. The positive corneal biopsy results confirmed the end-organ involvement criteria to qualify for a bone marrow transplant. This case demonstrates ocular involvement being the determining factor to proceed with a bone marrow transplant for a patient with multiple myeloma and shows how bilateral corneal crystalline deposits should prompt immediate investigation for systemic disease.
A Clarification and Call for a National Keratoplasty Registry
Robert C. O’Brien, PhD; Loretta B. Szczotka-Flynn, OD, PhD; Jonathan H. Lass, MD
doi : 10.1001/jamaophthalmol.2021.0716
JAMA Ophthalmol. 2021;139(6):676
To the Editor We were very pleased to read the thoughtful commentary by Dr Hallak1 on our recent article.2 The commentary refers to an analysis that was included in a submission prior to the final approved manuscript. We would like to clarify this situation. The earlier submission included a secondary analysis of variable importance for individual intraoperative complications in addition to the primary analysis with the grouped intraoperative complication variables; however, prompted by a reviewer comment, we decided to remove the former as the individual intraoperative complications were too infrequent to provide stable measures of variable importance (eg, 6 instances of flipping of the donor lenticule). In the final article, we removed any binary predictor variable with too few instances as well as some redundant variables to guard against unstable results and overfitting. To be able to assess the importance of individual intraoperative complications and truly be confident in the results would require a large consortium or registry database where these individual intraoperative complications were tracked, as in the Cornea Preservation Time Study.3 Such registry data have existed for solid organ transplantation since 1987,4 and we hope that in the near future similar data will exist for keratoplasty.
Dose-Response Models May Explain Age-Related Macular Degeneration and Vitamin Treatments
Kurt K. Benke, MSc, PhD; Janan Arslan, MSc, MBiostat
doi : 10.1001/jamaophthalmol.2021.1034
JAMA Ophthalmol. 2021;139(6):676-677
To the Editor The study by Christen et al,1 with associated commentary by Frank,2 has highlighted an interesting line of research that has produced mixed results. The objective of this study was to determine whether vitamin D3 (2000 IU per day) and marine ?-3 fatty acids (1 g per day) would prevent development or progression of age-related macular degeneration (AMD). The trial was secondary to the Vitamin D and Omega-3 Trial (VITAL). Christen et al1 concluded that there was no significant overall effect from either supplement on the incidence or progression of AMD. The authors noted previous studies have produced mixed results, often reporting inverse relationships between vitamin D and risk of AMD. These studies used cross-sectional, case-control, or prospective data, whereas this study used randomized trial data.
Dose-Response Models May Explain Age-Related Macular Degeneration and Vitamin Treatments—Reply
William G. Christen, ScD; Nancy R. Cook, ScD; JoAnn E. Manson, MD, DrPH
doi : 10.1001/jamaophthalmol.2021.1040
JAMA Ophthalmol. 2021;139(6):677
In Reply We agree with Benke and Arslan that a higher dose of ?-3 fatty acids may be required before a beneficial effect on age-related macular degeneration (AMD) incidence or progression can be observed. In the Vitamin D and Omega-3 Trial (VITAL),3 the doses for the study participants were chosen after consideration of their anticipated effects on the primary study end points of the parent VITAL trial (cardiovascular disease and cancer) and of their anticipated balance of benefits and risks in a primary prevention setting. The dose (1 g/d) of ?-3 fatty acids tested (eicosapentaenoic acid and docosahexaenoic acid) was the one recommended by the American Heart Association for cardioprotection1 and has been shown to be beneficial in a secondary prevention population.2 While the optimal dose for AMD prevention is unknown, subgroup analyses in our study provided no evidence that the lack of effect of ?-3 fatty acids on AMD occurrence was modified by baseline plasma ?-3 level or reported intake of fish.3
Biosimilar Ranibizumab (SB11) vs Reference Ranibizumab—Diving Deeper for Safety and Efficacy
Ashish Sharma, MD; Nilesh Kumar, MD; Nikulaa Parachuri, MD
doi : 10.1001/jamaophthalmol.2021.1037
JAMA Ophthalmol. 2021;139(6):677-679
To the Editor We read with great excitement the article by Woo et al.1 We congratulate the authors on the detailed analysis and for publishing the results of a new avenue in the treatment of neovascular age-related macular degeneration. Our group has been trying to understand various aspects of biosimilars in retinal diseases for the past 2 years.2,3 We have published on the regulatory aspects related to biosimilars in ophthalmology.4 We are curious to understand a few points in relation to the article by Woo et al.1
Biosimilar Ranibizumab (SB11) vs Reference Ranibizumab—Diving Deeper for Safety and Efficacy—Reply
Neil M. Bressler, MD
doi : 10.1001/jamaophthalmol.2021.1043
JAMA Ophthalmol. 2021;139(6):678-679
In Reply On behalf of my coauthors, I appreciate the interest of Sharma et al in biosimilars in ophthalmology. Regarding their first point, similar to previous reports on the low immunogenicity profile of Lucentis (ranibizumab),1,2 the incidence of antidrug antibodies (ADA) was also low for the reference ranibizumab group and comparable between the ranibizumab group and the proposed biosimilar SB11 group.3 No notable differences in pharmacokinetics (PK) were identified for presence of ADA; however, no formal statistical analysis could be undertaken because of the low incidence of ADA—only 3 of 40 individuals participating in the PK evaluation. For the PK analysis set, only 1 of these 3 individuals in the ranibizumab group was ADA positive at week 36, and serum concentration at week 36 was not lower than the concentration measured at any other time point. The other 2 individuals in the SB11 group were ADA positive at week 52 (end of study) only, so there were no PK data available for comparison with earlier visits.
