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Influence of Perfluorocarbon Liquid (LIQUID) During Pars Plana Vitrectomy on Retinal Vessel Displacement in Primary Macula-involving Rhegmatogenous Retinal Detachment

RecruitingNAAges 18 Years - anyAllNorfolk and Norwich University Hospitals NHS Foun…
NCT07027098 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rhegmatogenous retinal detachment (RRD) is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 people. Surgical interventions for treating RRD include pars plana vitrectomy (PPV), which currently represents the main adopted surgical choice. Main outcomes of successful RRD surgery have mainly been represented by anatomical retinal reattachment and best-corrected visual acuity (BCVA). Despite successful surgery, patients with mac-off RRD often report postoperative visual complaints of distortion such as metamorphopsia and scotomas in their central visual field, with great variability. Major advances in retinal imaging including wide-field optical coherence tomography (OCT) and fundus autofluorescence (FAF) allowed to investigate morphological changes after RRD surgery. The concept of retinal displacement - where the retina has reattached but the exact

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years of age, or older. * Diagnosis of primary MIRD with posterior vitreous detachment, and fovea off (confirmed with OCT) * Surgeons' decision that the patient is eligible for using gas as postoperative tamponade. * The surgeon is confident to proceed with surgery with or without the use of intraoperative PFCL Exclusion Criteria: * Previous RRD and/or RRD surgery in the study eye * Decision to use adjunct scleral buckle * Decision to use silicone oil as tamponade * Retinal detachment with macula on * Patients with other retinal pathologies causing permanent structural changes to the retina in the study eye, such as diabetic retinopathy (assessed above background, or any diabetic maculopathy), previous vascular occlusion (artery or vein occlusion), macula dystrophy, among others * Previous vitreoretinal surgery in the study eye * Inability to come for follow ups up to 3 months * Inability to take FAF and OCT imaging due to neck stiffness or other medical issue * Mental incapacity * Patient is unwilling or unable to follow or comply with all study related procedures or to sign informed consent form. * Contraindications for PFCL * Previous enrollment in a clinical trial involving retinal diseases and/or treatments * Media opacity leading to poor quality retinal images (not including post operative significant cataract. See section 7.11) * Patient inability to posture following surgery
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What it tests

  • Perflurocarbon liquid
  • Without Perflurocarbon liquid
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Where

1 site
Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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