Influence of Perfluorocarbon Liquid (LIQUID) During Pars Plana Vitrectomy on Retinal Vessel Displacement in Primary Macula-involving Rhegmatogenous Retinal Detachment
Recruiting now · Not applicable
Conditions studied: Retinal Displacement After Retinal Detachment Surgery
In brief
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 location has shifted, as evidenced by retinal vessel printing shown on post operative retinal imaging. Postoperative retinal displacement has been observed to occur with different frequency in relationship to variables including postoperative tamponade, surgical technique, and intraoperative use of perfluorocarbon liquids (PFCL). The investigators hope to formally study the impact of intraoperative use of PFCL, which is used as an aid during surgery to help flatten and position the retina, on retinal displacement. This will help us better understand the impact of this tool on outcomes both objectively through retinal imaging, and subjectively through visual outcomes including visual acuity and measures of distortion and other visual disturbances.
Key facts
- Study ID
- NCT07027098
- Run by
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- People needed
- 292
- Starts
- 2025-10-28
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Norwich University Hospitals NHS Foundation Trust — Norwich, Norfolk, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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