Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07027098

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

Led by Norfolk and Norwich University Hospitals NHS Foundation Trust · Updated on 2026-04-14

292

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age, or older.
  • Diagnosis of primary macula-involving rhegmatogenous retinal detachment with posterior vitreous detachment and detached fovea confirmed by OCT.
  • Surgeon's decision that the patient is eligible for gas as postoperative tamponade.
  • Surgeon confident to perform surgery with or without intraoperative perfluorocarbon liquid.
Not Eligible

You will not qualify if you...

  • Previous retinal detachment or retinal detachment surgery in the study eye.
  • Decision to use adjunct scleral buckle.
  • Decision to use silicone oil as tamponade.
  • Retinal detachment with macula on.
  • Other retinal diseases causing permanent structural retinal changes in the study eye, such as diabetic retinopathy above background, diabetic maculopathy, previous vascular occlusion, or macula dystrophy.
  • Previous vitreoretinal surgery in the study eye.
  • Inability to attend follow-ups up to 3 months.
  • Inability to undergo fundus autofluorescence and OCT imaging due to neck stiffness or other medical issues.
  • Mental incapacity.
  • Unwillingness or inability to comply with study procedures or provide informed consent.
  • Contraindications for perfluorocarbon liquid.
  • Previous enrollment in any clinical trial involving retinal diseases or treatments.
  • Media opacity causing poor quality retinal images (excluding postoperative significant cataract).
  • Inability to maintain postoperative positioning.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom, NR4 7UY

Actively Recruiting

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Research Team

F

Francesco Sabatino

CONTACT

S

Sean Zhou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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