Abstract

Topic: Retina

Purpose: Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) agents are pivotal in the treatment armamentarium of neovascular retinal diseases. Treat-and-extend (T&E) dosing aims to reduce cost barriers and the burden of frequent injections; however, the efficacy and safety of T&E versus other dosing regimens remains unclear. This meta-analysis comprehensively consolidates the data from published randomized clinical trials (RCTs) to answer this clinically relevant question.

Study design: Systematic review and meta-analysis.

Methods: We conducted a systematic literature search of Ovid MEDLINE, EMBASE, and Cochrane CENTRAL to September 2020. English-language RCTs reporting on efficacy and/or safety outcomes of T&E, bimonthly, monthly, and/or pro re nata (PRN) dosing regimens of anti-VEGF IVIs were included. Critical appraisal of trials for risk of bias and strength of evidence was performed using the Cochrane and GRADE guidelines, respectively. The primary outcome was improvement in best-corrected visual acuity (BCVA), while secondary outcomes included changes in central subfield thickness (CSFT), mean number of injections, mean number of follow-up visits, and incidence of adverse events. All outcomes were collected at last follow-up. Meta-analyses were conducted using a random effects model. If data were available, subgroup analyses were performed based on IVI agent and retinal disease.

Results: Across 11 included RCTs, 1140 eyes were treated with a T&E IVI dosing regimen, 866 with monthly, 123 with bimonthly, and 253 with PRN-dosed IVIs. One of 11 trials had a target follow-up of 6 months, five of 12 months, and five of 24 months (mean: 16.4 ± 7.0 months per eye). Across all trials, risk of bias was generally low-to-moderate. Mean change in BCVA and CSFT at last follow-up were non-significantly different between T&E versus monthly (P = 0.23 and 0.22, respectively), bimonthly (P = 0.88 and 0.18, respectively), and PRN (P = 0.30 and 0.54, respectively) dosing regimens. T&E conferred significantly fewer injections versus monthly (P < 0.001) but significantly higher injections versus PRN (P < 0.001) dosing regimens by final follow-up. There was no significant difference in safety outcomes amongst comparators.

Conclusions: Efficacy and safety differences are non-significant between T&E, bimonthly, monthly, and PRN regimens. T&E confers a statistically significant benefit of reduced injection burden relative to monthly dosing and reduced clinic visits relative to PRN. T&E remains efficacious while potentially enhancing patient satisfaction, improving treatment adherence, stabilizing visual function, conferring cost savings, and aiding in capacity planning to treat neovascular retinal disease.

Presentations

1. Nichani P, Popovic MM, Dhoot AS, Pathak A, Muni RH, Kertes PJ. (2021). Comparison of treat-and-extend to monthly and as-needed dosing of intravitreal anti-vascular endothelial growth factor agents: A meta-analysis of randomized controlled trials. Canadian Ophthalmological Society Annual Meeting & Exhibition, Virtual Meeting (ePoster). View presentation, references, and conflicts of interest here.

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Please contact Prem Nichani for a copy of the Abstract as it is not officially accepted by nor published in a scholarly journal. Currently under review at Ophthalmology Retina.

Presentations

1. Popovic MM, Nichani P, Dhoot AS, Pathak A, Muni RH, Kertes PJ. (2021). Treat-and-extend dosing of intravitreal anti-VEGF agents in neovascular age-related macular degeneration: A meta-analysis of 1697 eyes. UofT Department of Ophthalmology & Vision Sciences 62nd Research Day, Toronto, Ontario, Canada (ePoster). View presentation, references, and conflicts of interest here.

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Presentations

1. Nichani P, Popovic MM, Muni RH, Mireskandari K, Tehrani NN, Kertes PJ. (2020). Intravitreal injections versus laser photocoagulation for retinopathy of prematurity: A meta-analysis of 3701 eyes. American Academy of Ophthalmology, Las Vegas, NV, United States (ePoster). Spotlighted by OphthalmologyAdvisor.com and PracticeUpdate.com. View ePoster with narration here.
2. Popovic MM, Nichani P, Muni RH, Mireskandari K, Tehrani NN, Kertes PJ. (2020). Intravitreal injections versus laser photocoagulation for retinopathy of prematurity: A meta-analysis of 3701 eyes. European Society of Retina Specialists EURetina, Virtual Meeting (oral). View presentation here.
3. Popovic MM, Nichani P, Muni RH, Mireskandari K, Tehrani NN, Kertes PJ. (2020). Intravitreal injections versus laser photocoagulation for retinopathy of prematurity: A meta-analysis of 3701 eyes. UofT Department of Ophthalmology & Vision Sciences 62nd Research Day, Toronto, ON (oral). Alumni Award for Best Resident Research Presentation. View presentation here.

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1. Micieli JA, Nichani P. (2020). Granuloma annulare, scalp necrosis, and ischemic optic neuropathy from giant cell arteritis after varicella-zoster virus vaccination. Canadian Ophthalmological Society Annual Meeting & Exhibition, Vancouver, BC (ePoster).

Notes

COS2020 Reference List:

1. Hoffman GS. Giant cell arteritis. Ann Int Med. 2016;165:ITC65-80.
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3. Devaraj NK. Giant cell arteritis: where did we go wrong? Fortune J Rheumatol. 2019;1:12-4.
4. Weyand CM, Liao YJ, Goronzy JJ. The immunopathology of giant cell arteritis: diagnostic and therapeutic implications. J Neuroophthalmol. 2012;32:259–265.
5. Helweg-Larsen J, Tarp B, Obel N, Baslund B. No evidence of parvovirus B19, Chlamydia pneumoniae or human herpes virus infection in temporal artery biopsies in patients with giant cell arteritis. Rheumatol (Oxford). 2002;41:445–9.
6. Ing EB, Ing R, Liu X, Zhang A, Torun N, et al. Does herpes zoster predispose to giant cell arteritis: a geo-epidemiologic study. Clin Ophthalmol. 2018;12:113–118.
7. Lotan I, Steiner I. Giant cell arteritis following varicella zoster vaccination. J Neurol Sci. 2017;375:158–9.
8. Gilden D, White T, Khmeleva N, Heintzman A, Choe A, et al. Prevalence and distribution of VZV in temporal arteries of patients with giant cell arteritis. Neurology. 2015;85:1914–5.
9. Nagel MA, White T, Khmeleva N, Rempel A, Boyer PJ, et al. Analysis of varicella-zoster virus in temporal arteries biopsy positive and negative for giant cell arteritis. JAMA Neurol. 2015;72:1281–7.
10. Perez C, Loza E, Tinture T. Giant cell arteritis after influenza vaccination. Arch Intern Med. 2000;160:2677.
11. Shoenfeld Y, Agmon-Levin N. “ASIA”—autoimmune/ inflammatory syndrome induced by adjuvants. J Autoimmun. 2011;36:4–8.
12. Torisu Y, Horai Y, Michitsuji T, Kawahara C, Mori T, et al. Giant cell arteritis with generalized granuloma annulare. Intern Med. 2019;58:1173–1177.
13. Fukai K, Ishii M, Kobayashi H, Someda Y, Hamada T, et al. Generalized granuloma annulare in a patient with temporal arteritis: are these conditions associated? Clin Exp Dermatol. 1990;15:70–2.
14. Kluger N, Riviere S, Mura M, Guillot B, Girard C. Simultaneous occurrence of generalized granuloma annulare, anterior uveitis and giant cell arteritis: coincidental or not? Presse Med. 2012;41:548–9.
15. Yanez S, Val-Bernal JF, Pena-Sagredo JL. Granuloma annulare and giant cell arteritis. Clin Exp Rheumatol. 2008;3:S108–10.
16. Günes ̧ P, Göktay F, Mansur AT, Köker F, Erfan G. Collagen-elastic tissue changes and vascular involvement in granuloma annulare: a review of 35 cases. J Cutan Pathol. 2009;36:838–44.

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Purpose: Micro-invasive glaucoma surgery (MIGS) is a less traumatic and potentially safer surgical method for patients with open-angle glaucoma. However, it is a recent development for which the high-quality literature must be evaluated.

Study design: Systematic review.

Methods: A review of MIGS was conducted by searching Ovid MEDLINE, EMBASE, and Cochrane CENTRAL (2006 to 2019). The primary efficacy indicators were reductions in intraocular pressure (IOP) and topical medication use postoperatively. Adverse event analysis was conducted; risk of bias assessment was performed using the Cochrane, Newcastle-Ottawa, and World Glaucoma Association recommendations.

Results: From 10076 articles identified, 3476 baseline eyes across 20 trials met all eligibility criteria and were included. The mean age was 69.5 ± 2.9, 53.7% were female, 77.4% were Caucasian, and 80% of included studies were randomized controlled trials. One study had last follow-up at less than one year, fifteen studies had follow-up extending 1-2 years, and four had longer than two years of follow-up. MIGS procedures or devices assessed included ab interno canaloplasty (ABiC), cyclophotocoagulation (CPC), CyPass^® Micro-Stent, excimer laser trabeculotomy (ELT), Hydrus^® Microstent, iStent^® (1^st generation), iStent^® inject (2^nd generaton), Kahook Dual Blade^®, micropulse (MDLT), Trabectome^®, and XEN^® Gel Stent. A pattern of more significant IOP and medication reduction was observed in patients who received a MIGS device relative to control intervention. Across all studies at last follow-up, the mean IOP reduction was 8.0 ± 2.2 mmHg (n = 2067; range: 2.4–16.5 mmHg) vs. 7.1 ± 3.3 mmHg (n = 1234; range: 1.7–16 mmHg) and the mean reduction of topical medications was 1.4 ± 0.4 (n = 1864; range: -0.2–3 mmHg) vs. 1.0 ± 0.7 (n = 1234; range: -1–3 mmHg) in MIGS vs. control eyes, respectively. The 1^st generation iStent had the most literature supporting its efficacy, followed by the Hydrus. Adverse events were more common among phaco-only eyes (42.3%) vs. standalone-MIGS eyes (21.9%); the rate was 45.0% for phaco-MIGS eyes. The most common adverse events following MIGS implantation included stent obstruction, inflammation, and repeat surgical intervention.

Conclusions: Overall, there is some evidence to support the role of trabecular bypass and suprachoroidal MIGS devices in the treatment armamentarium for glaucoma. MIGS can effectively reduce IOP, decrease the number of topical medications taken, and minimize the number of complications associated with more invasive surgical devices, thus improving quality of life. We await the upcoming RCT evidence from other MIGS devices including the XEN^® Gel Stent and InnFocus MicroShunt and hope through this iterative process to elucidate the comparative efficacy, safety, and future role of MIGS in the glaucoma surgical paradigm.

Keywords: MIGS; ocular drainage implant; glaucoma surgery; filtration surgery; open-angle glaucoma; IOP reduction

Presentations

1. Nichani P, Popovic M, Schlenker MB, Park J, Ahmed IIK. (2020). Micro-invasive glaucoma surgery: A selected review of studies. Canadian Ophthalmological Society Annual Meeting & Exhibition, Virtual Meeting (ePoster). 2^nd Place Poster Award. View presentation, references, and conflicts of interest here.
2. Nichani P, Popovic M, Schlenker MB, Park J, Ahmed IIK. (2020). Micro-invasive glaucoma surgery: A selected review of studies. UofT Department of Ophthalmology & Vision Sciences 62nd Research Day, Toronto, Ontario, Canada (oral). View presentation, references, and conflicts of interest here.

Notes

Studies Included in Analysis:

1. Ab Interno Canaloplasty (ABiC)
   • Gandolfi; J Ophthalmol. 2016;2016:3410469 .
2. Micropulse Cyclophotocoagulation (CPC)
   • Aquino; Clin Exp Ophthalmol. 2015;43(1):40-6. (NCT00349414)
3. CyPass® Micro-Stent
   • Vold; Ophthalmology. 2016;123(10):2103-12. (NCT01085357)
4. Excimer Laser Trabeculectomy
   • Babighian; Eye. 2010;24(4):632-8.
5. Hydrus® Microstent
   • Samuelson; Ophthalmology. 2019;126(1):29-37. (NCT01539239)
   • Pfeiffer; Ophthalmology. 2015;122(7):1283-93. (NCT01818115)
6. Hydrus® Microstent vs. iStent®
   • Ahmed; Ophthalmology. 2019:1-10. (NCT02023242)
7. iStent® (G1) and iStent® Inject (G2)
   • Samuelson; Ophthalmology. 2019;126(6):811-21. (NCT00323284)
   • Katz; Clin Ophthalmol. 2018;12:255-62. (NCT01517477)
   • Vold; Ophthalmol Ther. 2016;5(2):161-72. (NCT01443988)
   • Fea; Clin Ophthalmol. 2014;8:875-82.
   • Samuelson; Ophthalmology. 2011;118(3):459-67. (NCT00323284)
   • Fernández-Barrientos; Invest Ophthalmol Vis Sci. 2010;51(7):3327-32. (NCT00326066)
8. Kahook Dual Blade® (KDB)
   • Le; Adv Ther. 2019;36(9):2515-27.
9. Micropulse Diode Laser Trabeculoplasty (MDLT)
   • Detry-Morel; Bull Soc Belge Ophtalmol. 2008;(308):21-8.
10. Trabectome®
    • Sato; BMJ Open Ophthalmol. 2018;3(1):1-7. (UMIN000021170)
    • Ting; Can J Ophthalmol. 2018;53(6):588-94. (NCT00901108)
11. XEN® Gel Stent
    • Schlenker; Ophthalmology. 2017;124(11):1579-88.

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Purpose: This analysis aims to: 1) determine the frequency and source of eyeglass insurance coverage in Ontario and changes from 2003 to 2013/14; 2) examine socio-demographic factors associated with eyeglass insurance; and 3) investigate if having eyeglass insurance is associated with increased use of eye care providers in a publicly-funded healthcare system.

Methods: Cross-sectional data from Ontario respondents aged 12+ to the Canadian Community Health Survey in 2003 (n=42,777), 2005 (n=41,766) and 2013/14 (n=42,553) was analyzed.

Results: Insurance covered all or part of the cost of prescription eyewear for 62.3% of Ontarians in 2003, 62.1% in 2005, and 62.0% in 2013/14. In 2005, 86% of those covered had employer-sponsored insurance, 9% had government-sponsorship, and 6% had a private plan. Corresponding numbers were 84%, 10% and 7% in 2013/14. From 2005 to 2013/14, government coverage increased from 29% to 42% (p<0.0001) for those without a secondary school diploma and from 30% to 38% (p<0.0001) for those with household income under middle-level. Employer-sponsored coverage remained unchanged (92%) for individuals with household income above middle-level but decreased from 67% to 55% (p<0.0001) for Ontarians without a secondary school diploma and from 64% to 53% (p<0.0001) for those with under middle-level income. An estimated 4.2 million Ontarians did not have any source of insurance in 2013/14.

In all survey years, factors associated with having insurance were age <65, post-secondary education, household income above middle-level, aboriginal status, and those in married/common-law relationships.

In age groups with routine eye exams covered by government, having eyeglass insurance versus none was associated with increased use of eye care providers with a difference of 6% for the 12-19 group and 7% for the 65+ group. Among those without government-funded routine eye exams, the difference in use of eye care providers between those with and without eyeglass insurance was 15% for the 20-39 group and 11% for the 40-64 group.

Conclusions: Eyeglass insurance coverage was 62% in Ontario and varied little from 2003 to 2013/14. The largest source of insurance was employer-sponsored, primarily covering high income earners; government insurance significantly increased in lower income and education groups in recent years. Having eyeglass insurance was associated with significantly increased use of eye care providers.

Acknowledgements: This research was supported by funds to the Canadian Research Data Centre Network (CRDCN) from the Social Science and Humanities Research Council (SSHRC), the Canadian Institute for Health Research (CIHR), the Canadian Foundation for Innovation (CFI) and Statistics Canada. Although the research and analysis are based on data from Statistics Canada, the opinions expressed do not represent the views of Statistics Canada or the Canadian Research Data Centre Network (CRDCN).

Presentations

1. Nichani P, Trope GE, Buys YM, Markowitz SN, Liu, SY, Ngo G, Markowitz M, Jin YP. (2019). Frequency and source of eyeglass insurance coverage in Ontario: Results from 2003 to 2013/14. Canadian Ophthalmological Society Annual Meeting & Exhibition, Québec City, QC (oral). View presentation here.
2. Nichani P, Trope GE, Buys YM, Markowitz SN, Liu, SY, Ngo G, Markowitz M, Jin YP. (2019). Frequency and source of eyeglass insurance coverage in Ontario: Results from 2003 to 2013/14. UofT Department of Ophthalmology & Vision Sciences 61st Research Day, Toronto, ON (poster). View poster here.
3. Nichani P, Trope GE, Buys YM, Markowitz SN, Liu, SY, Ngo G, Markowitz M, Jin YP. (2019). Frequency and source of eyeglass insurance coverage in Ontario: Results from 2003 to 2013/14. Invest Ophthalmol Vis Sci, 60(9):5451. Association for Research in Vision and Ophthalmology Annual Meeting, Vancouver, ON (poster). View poster here.

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Background: Vision problems due to refractive error are common (57%) and readily correctable by prescription eyewear; however, the cost is significant.

Hypothesis: Access to eyeglass insurance varies by age. Individuals without coverage are less likely to consult an eye care provider, leading to increased prevalence of treatable visual impairment (VI).

Research Questions: The analysis aims to: (1) determine the frequency and source of eyeglass insurance coverage and the influence of age; and (2) examine associations between eyeglass insurance coverage, utilization of eye care providers, and prevalence of VI.

Methods: Data from Ontario respondents aged 18+ (n=42,553) from the 2013/14 Canadian Community Health Survey was analyzed.

Results: Prescription eyewear was covered in part or in full for 62% of Ontarians. Insurance coverage was highest in people aged 40-64 (71%) and lowest in those aged 75+ (35%). Of those covered by insurance, 84% were sponsored by employers, 10% by government, and 7% by private purchase. For Ontarians aged 65-74 and 75+, government-sponsored coverage increased to 15% and 25%, and private-purchased coverage increased to 22% and 18%.

For those without eyeglass coverage, the utilization of eye care providers was nearly half (25%) of those with coverage (46%). Ontarians without eyeglass coverage had increased prevalence of VI (1.5%) vs. those with coverage (0.9%).

Conclusions: Access to eyeglass insurance varies by age. The largest source of insurance was employer-sponsored; government-sponsored or private-purchased insurance increased in those aged 65+. Lack of insurance was associated with decreased utilization of eye care providers and increased prevalence of VI.

Acknowledgments: This research was supported by funds to the Canadian Research Data Centre Network (CRDCN) from the Social Science and Humanities Research Council (SSHRC), the Canadian Institute for Health Research (CIHR), the Canadian Foundation for Innovation (CFI) and Statistics Canada. Although the research and analysis are based on data from Statistics Canada, the opinions expressed do not represent the views of Statistics Canada or the Canadian Research Data Centre Network (CRDCN).

Presentations

1. Nichani P, Trope GE, Buys YM, Markowitz SN, Markowitz M, Jin YP. (Aug 2018). Eyeglass insurance coverage in Ontario and its association with utilization of eye care providers and prevalence of self-reported visual impairment. UofT Institute of Medical Science Summer Undergraduate Research Program Research Day, Toronto, ON (poster). 1^st Place Poster Award. View poster here.

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Presentations

1. Nichani P, Coleman T, Coulombe S, Manwell LA, Wilson CL, Travers RN. (Mar 2017). Awareness of and access to LGBTQ-friendly services among racialized sexual and gender minorities: Insights from the Outlook Study. Wilfrid Laurier University Department of Health Sciences Thesis Poster Day, Waterloo, ON (poster). View poster here.

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Background: Past research indicates that men who have sex with men (MSM) are increasingly using technology to meet other men seeking sexual contact with men (Grov, Breslow, Newcomb, Rosenberger, & Bauermeister, 2014). This practice allows for anonymity while gaining a sense of control and security not accessible in face-to-face encounters (McKie, Lachowsky, & Milhausen, 2015). However, many negative outcomes of technology use in sex- seeking MSM have also been noted (e.g. jealousy, deception; McKie, Milhausen, Lachowsky, 2016). Research has also shown that MSM are more likely to use non-verbal cues to express their sexual consent (Beres, Herold, & Maitland, 2004). However, no research has examined sexual negotiation occurrences via online modalities in MSM.

Research Questions: This research aims to explore how MSM seek sexual partners on text-based interfaces (phone applications and websites), specifically focusing on how these men negotiate sexual consent and set boundaries. We also wanted to establish which online sources they were meeting other MSM from.

Method: Participants were 317 MSM, aged 18-76 (M = 32) from Canada, the US, and Western Europe. Data were obtained from a larger study on sexual consent challenges of men of varying sexual orientations internationally. The present data were collected using an online qualitative survey, which asked how technology (websites and cell phone applications) was used to seek sexual partners, how technology changed the process of seeking partners, and how sexual boundaries were set on these interfaces. The current analysis utilized Braun and Clarke’s (2006) thematic analysis technique. MSM were also asked which websites and cellphone applications they used to meet other men.

Results: A frequency table was produced using the websites/cellphone applications that MSM reported using most frequently. Further, via the thematic analysis, themes relating to challenges in sexual negation, unique barriers for MSM, and expectations of MSM emerged.

Conclusions: While not all MSM reported having challenges setting sexual boundaries and sticking to them, many did. As such, some MSM face difficulties relating to navigating sexual spaces online.

Implications: The use of text-based and online interfaces to seek sexual partners is rapidly increasing, especially within LGBTQ communities. As such, investigations of both partner seeking behaviours, and sexual consent using these modalities are important. Exploring boundary setting online could elucidate issues with sexual consent on text-based interfaces, and assist in developing strategies to combat sexual coercion in these contexts. Directions for future research will also be discussed.

Presentations

1. Nichani P*, Al-far W*, Rudzinski A, Bell K, McKie RM, Humphreys TP, Travers RN. (Sep 2016). Seeking sexual partners and boundary setting among MSM on text-based interfaces. Canadian Sex Research Forum, Québec City, QC (poster). View poster here.

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