Ethical Concerns in Potentially Harmful Procedures in Ophthalmic Clinical Studies

2021 ◽  
Author(s):  
Piotr Kanclerz ◽  
Andrzej Grzybowski ◽  
Francisco Ascaso
Keyword(s):  
Standard Of Care ◽  
Ethics Committees ◽  
Age Related Macular Degeneration ◽  
Control Group ◽  
Vitreomacular Adhesion ◽  
Age Related ◽  
Clinical Investigations ◽  
Invasive Techniques ◽  
Study Designs ◽  
Endothelial Growth Factor

Importance In clinical research, ethical principles and practice must be transparent, clearly defined and monitored. We believe that potentially harmful and non-beneficial interventions in diagnostic and placebo-controlled ophthalmology research should be avoided. We advise on alternative study designs and make recommendations for both researchers and research ethics committees. Observations We discuss the use of potentially harmful diagnostic interventions in clinical investigations, e.g., lumbar puncture in glaucoma patients, and sham saline solution injections in eyes with vitreomacular adhesion. In placebo-controlled research studies, patients in the control group commonly did not receive the standard of care for the condition under consideration, e.g., antiglaucoma therapy in a glaucoma study, anti-vascular endothelial growth factor agents in neovascular age-related macular degeneration or central retinal vein occlusion. Testing new methods and treatments against no intervention control, especially invasive placebo, rather than the usual standard of care, where one exists should not be recommended. Conclusions/Relevance Invasive and potentially harmful procedures in ophthalmology can be replaced by alternative non-invasive techniques or by an analysis of patients undergoing the procedure of interest for other purposes.

Diagnosing and Treating Vitreomacular Adhesion

2011 ◽  
Vol 05 (01) ◽  
pp. 69 ◽  
Author(s):  
Paolo Carpineto ◽  
Luca Di Antonio ◽  
Agbeanda Aharrh-Gnama ◽  
Vincenzo Ciciarelli ◽  
Leonardo Mastropasqua ◽  
...  
Keyword(s):  
Posterior Vitreous Detachment ◽  
Standard Of Care ◽  
Age Related Macular Degeneration ◽  
Vitreomacular Traction ◽  
Vitreous Surgery ◽  
Vitreomacular Adhesion ◽  
Current Standard ◽  
Vitreous Detachment ◽  
Age Related ◽  
23 Gauge

Perifoveal vitreous detachment with residual vitreofoveal adhesion is considered as the first stage of posterior vitreous detachment. A key point is the transition from an innocuous vitreomacular adhesion (VMA) to a pathological vitreomacular traction (VMT). By using optical coherence tomography (OCT), VMA is defined as adhesion of the posterior hyaloid cortex involving the centre of the foveal region with or without a hyper-reflective signal on the inner surface of the retina. VMT is diagnosed when the inner macular surface slopes steeply, or sharp angulation and localised deformation of the retinal profile is detected at the VMA site. Otherwise, VMA is simply considered to be persistent adherence of the cortical vitreous. The tractional effects of perifoveal vitreous detachment cause a variety of macular pathologies determined by the size and the strength of the residual vitreoretinal adhesion. Vitreomacular adhesion plays a major role in the development of diseases such as vitreomacular traction syndrome (VMTS), macular hole, epiretinal membrane, tractional macular oedema and myopic macular retinoschisis. In addition, clinical evidence supports the theory that the course of diabetic retinopathy and age-related macular degeneration may be strongly influenced by an incomplete posterior vitreous separation. The current standard of care of vitreomacular interface pathologies is vitrectomy and membrane peeling – a procedure that is thought to relieve epiretinal traction – followed by regeneration of the retinal architecture and recovery of visual function. Over the last few years, with the introduction of 25-gauge (0.50mm) and 23-gauge (0.72mm) instruments, there has been another major shift toward transconjunctival microincisional vitrectomy surgery (MIVS). Pharmacological induction of posterior vitreous detachment (PVD) can become a further step toward a real ‘minimally invasive vitreous surgery’ for VMTS.

scholarly journals Vitreomacular Adhesion, Vitreomacular Traction, and Concurrent Diseases

2018 ◽  
pp. 256-261
Keyword(s):  
Posterior Vitreous Detachment ◽  
Age Related Macular Degeneration ◽  
Optic Coherence Tomography ◽  
Retinal Diseases ◽  
Vitreomacular Adhesion ◽  
Vitreous Detachment ◽  
Age Related ◽  
Vitreomacular Interface ◽  
Vascular Occlusions ◽  
Endothelial Growth Factor

The introduction of the optic coherence tomography in ophthalmology has been enabled us to understand the relationship between vitreomacular interface pathologies and concurrent retinal diseases. It is known that vitreomacular adhesion (VMA) and traction (VMT) develops as a result of an incomplete posterior vitreous detachment. VMA/VMT usually coincidence with age-related macular degeneration, diabetic macular edema, and retinal vascular occlusions. Some studies suggested that the complete posterior vitreous detachment is protective against these kinds of retinal diseases. It is proclaimed that VMA/VMT may have a role in the etiology and progression of these retinal diseases. And also, in the majority of the studies, it is proposed that VMA/VMT may interfere with the treatment and even worsen the result of the anti-vascular endothelial growth factor (Anti-VEGF) therapy which is used within the treatment regime of these retinal diseases. It is obvious that further studies are needed to clarify the cause-result relationship and the effectiveness of the treatment for the concurrent retinal diseases.

scholarly journals Effects of Vitreomacular Adhesion on Age-Related Macular Degeneration

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Eui Chun Kang ◽  
Hyoung Jun Koh
Keyword(s):  
Macular Degeneration ◽  
Standard Treatment ◽  
Age Related Macular Degeneration ◽  
Vascular Endothelial ◽  
Neovascular Amd ◽  
Vitreomacular Adhesion ◽  
Anti Vegf ◽  
Age Related ◽  
Meta Analyses ◽  
Endothelial Growth Factor

Herein, we review the association between vitreomacular adhesion (VMA) and neovascular age-related macular degeneration (AMD). Meta-analyses have shown that eyes with neovascular AMD are twice as likely to have VMA as normal eyes. VMA in neovascular AMD may induce inflammation, macular traction, decrease in oxygenation, sequestering of vascular endothelial growth factor (VEGF), and other cytokines or may directly stimulate VEGF production. VMA may also interfere with the treatment effects of anti-VEGF therapy, which is the standard treatment for neovascular AMD, and releasing VMA can improve the treatment response to anti-VEGF treatment in neovascular AMD. We also reviewed currently available methods of relieving VMA.

scholarly journals Management of a Submacular Hemorrhage Secondary to Age-Related Macular Degeneration: A Comparison of Three Treatment Modalities

2020 ◽  
Vol 9 (10) ◽  
pp. 3088
Author(s):  
Seongyong Jeong ◽  
Dong-Geun Park ◽  
Min Sagong
Keyword(s):  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Treatment Modalities ◽  
Submacular Hemorrhage ◽  
Visual Improvement ◽  
Anti Vegf ◽  
Age Related ◽  
Pneumatic Displacement ◽  
Invasive Techniques ◽  
Endothelial Growth Factor

This paper aims to compare the effects of three treatment modalities for a submacular hemorrhage (SMH) secondary to exudative age-related macular degeneration (AMD). Seventy-seven patients with an SMH were divided into three groups: small-sized (optic disc diameter (ODD) ≥ 1 to < 4), medium-sized (ODD ≥ 4 within the temporal arcade) and large-sized (ODD ≥ 4, exceeding the temporal arcade). Patients received anti-vascular endothelial growth factor (anti-VEGF) monotherapy, pneumatic displacement (PD) with anti-VEGF or a vitrectomy with a subretinal tissue plasminogen activator (tPA) and gas tamponade based on the surgeon’s discretion. The functional and anatomical outcomes were evaluated. Among the 77 eyes, 45 eyes had a small-sized, 21 eyes had a medium-sized and 11 eyes had a large-sized SMH. In the small-sized group, all treatment modalities showed a gradual best-corrected visual acuity (BCVA) improvement with high hemorrhagic regression or displacement rates (over 75%). In the medium-sized group, PD and surgery were associated with better BCVA with more displacement than anti-VEGF monotherapy (67% and 83%, respectively, vs. 33%). In the large-sized group, surgery showed a better visual improvement with a higher displacement rate than PD (86% vs. 25%). Our findings demonstrated that visual improvement can be expected through appropriate treatment strategy regardless of the SMH size. In cases with a larger SMH, invasive techniques including PD or surgery were more advantageous than anti-VEGF monotherapy.

Current Best Clinical Practices—Management of Neovascular AMD

2017 ◽  
Vol 1 (5) ◽  
pp. 294-297 ◽  
Author(s):  
David Brown ◽  
Jeffrey S. Heier ◽  
David S. Boyer ◽  
K. Bailey Freund ◽  
Peter Kaiser ◽  
...  
Keyword(s):  
Vision Loss ◽  
Standard Of Care ◽  
Age Related Macular Degeneration ◽  
Vascular Endothelial ◽  
Clinical Practices ◽  
Central Vision Loss ◽  
Age Related ◽  
Subretinal Fibrosis ◽  
Endothelial Growth Factor ◽  
Hallmark Feature

The hallmark feature of the wet or neovascular form of age-related macular degeneration is the presence of choroidal (or retinal) neovascularization (CNV). If left untreated, CNV may result in significant central vision loss due to complications including exudation, leakage, and ultimately subretinal fibrosis causing remarkable photoreceptor loss. Although the mechanism of development is not fully understood, the process of neovascularization is driven by the upregulation of angiogenic cytokines, principally vascular endothelial growth factor (VEGF). Inhibition of VEGF with intravitreal anti-VEGF therapy has become the standard of care for macular CNV, helping to prevent legal blindness in millions of affected patients worldwide.

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