ArticleBMJ open2021
Two-step versus 1-step subretinal injection to compare subretinal drug delivery: a randomised study protocol.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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0 citing papers in PubMed, 5 citations in OpenAlex.
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThere is increasing interest in subretinal injections as a surgical procedure, largely as a result of emerging treatments for ocular diseases which necessitate this manoeuvre. However, surgical variables in the efficacy of such treatments have to date been largely overlooked and the proportion of drug which reaches the intended compartment of the subretinal space remains unknown. Our aims are twofold: first, to determine the proportion of subretinally injected medication retained following surgical delivery and second, to compare two different techniques of injection ('1-step' vs '2-step').
methodsWe outline a randomised controlled trial of subretinal injection of alteplase following vitrectomy for the management of submacular haemorrhage secondary to age-related macular degeneration. Patients will be randomised to receive either 1-step injection, where the therapeutic solution simultaneously defines the surgical plane or 2-step injection, where the surgical plane is first identified with balanced salt solution prior to injection of subretinal alteplase, as outlined below. Sodium fluorescein will be used as an optical label to track drug reflux into the vitreous cavity using quantitative protocols established in our laboratory. All patients will undergo fluid air exchange at the completion of surgery, with injection of bevacizumab 1.25 mg and 20% sulfahexafluoride gas as the vitreous substitute (both of which may help improve outcomes). Alteplase, sodium fluorescein and bevacizumab will all be used for off-label indications in the trial. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the South Eastern Sydney Local Health District's Human Research Ethics Committee (HREC 17/092). The results of this trial will be disseminated in peer-reviewed proceedings (associated with conference presentation) and in scholarly journals. TRIAL REGISTRATION NUMBER: ACTRN12619001121156.
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