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RecruitingNCT07027098LIQUIDUpdated Apr 14, 2026

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

An interventional study of Perflurocarbon liquid and Without Perflurocarbon liquid in Retinal Displacement After Retinal Detachment Surgery, sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
292
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Rhegmatogenous retinal detachment (RRD) is an acute, sight threatening condition, resulting from the separation of the neurosensory retina from the underlying retinal pigment epithelium (RPE). It is caused by at least one retinal break and recruitment of intraocular fluid into the subretinal space. Surgical interventions for treating RRD include pars plana vitrectomy (PPV), which currently represents the most widely adopted surgical choice, scleral buckling (SB) and pneumatic retinopexy (PnR).

Significant visual loss is the main complaint of patients with macula-involving RRD (MIRD). Hence, the main outcomes of successful RRD surgery have historically been represented by postoperative anatomical retinal reattachment and best-corrected visual acuity (BCVA). However, despite successful surgery, patients with MIRD often report postoperative visual complaints of distortion such as metamorphopsia, aniseikonia and scotomas in their central visual field, with great variability.

Major advances in retinal imaging contributed to provide a better understanding of postoperative visual complaints after surgery for RRD. In particular, optical coherence tomography (OCT) highlighted drop-out of the ellipsoid zone (EZ) or outer and inner retinal folds in the macula area. However, only more recently, hyperautofluorescent lines, also called Retinal Vessel Printing (RVP), adjacent to the retinal blood vessels, were noted on autofluorescence imaging in patients who underwent RRD surgery. This finding is believed to be secondary to unintentional retinal displacement after RRD surgery and may serve as a surrogate anatomical marker of postoperative metamorphopsia and central scotomas.

Postoperative retinal displacement is potentially influenced by several variables including intraocular tamponade, adopted surgical technique, intraoperative use of perfluorocarbon liquids (PFCL) and postoperative posture. The effect of PFCL on retinal displacement is currently unknown due to lack of RCTs and significant limitations of previous research. Therefore, the aim of this RCT is to investigate the role of intraoperative PFCL on postoperative retinal displacement in patients with MIRD undergoing PPV with immediate postoperative face-down posture.

The investigators aim to evaluate whether intraoperative PFCL affects the incidence and patterns of postoperative retinal displacement. As secondary outcomes, this RCT will also investigate the effect of intraoperative use of PFCL on functional outcomes, e.g. BCVA, metamorphopsia and aniseikonia. All patients participating in the trial will be randomly allocated to having surgery either with or without the use of PFCL, and will be followed up regularly after surgery for up to 6 months.

02

Conditions studied

  • Retinal Displacement After Retinal Detachment Surgery

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Keywords

  • Retinal displacement
  • retinal detachment
  • Heavy liquid
  • perfluorocarbon liquids
03

In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's planned enrollment of 292 is above the median of 50 across 132 interventional studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust is the lead sponsor of 30 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 form.
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
292 participants (estimated)

Study arms

  • Experimental
    Retinal Detachment Surgery (Vitrectomy) With Perflurocarbon liquid use.

    Standard retinal detachment surgery (vitrectomy) with the use of Perflurocarbon liquid (PFCL) to stabilise macular during surgery and drainage of subretinal fluid. PFCL is then fully removed before the end of surgery.

    Procedure: Perflurocarbon liquid

  • Active comparator
    Retinal Detachment Surgery (Vitrectomy) Without Perflurocarbon liquid use.

    Standard retinal detachment surgery (vitrectomy) without the use of Perflurocarbon liquid (PFCL).

    Procedure: Without Perflurocarbon liquid

Interventions

  • ProcedurePerflurocarbon liquid

    Used to facilitate surgery of retinal detachment to stabilise macular during surgery.

  • ProcedureWithout Perflurocarbon liquid

    Standard retinal detachment surgery (vitrectomy) without the use of Perflurocarbon liquid (PFCL).

06

What researchers measure

Primary outcomes

  1. Retinal Displacement

    Number of patients with presence of retinal displacement on post operative retinal imaging (FAF) between groups with PFCL use and without PFCL use.

    Time frame: 3 months post operation

Secondary outcomes

  1. Best-Corrected Visual Acuity

    Average change in visual acuity (BCVA) in groups with PFCL and without PFCL use

    Time frame: Baseline, 2 weeks, 3 months, and 6 months (at discretion of research team, see protocol)

  2. Metamorphopsia

    Average M-CHARTS score comparison between groups with PFCL use and without PFCL use.

    Time frame: 3 months post operation

  3. Quantification of retinal displacement

    Retinal displacement distance as measured on retinal imaging (FAF) in millimetres.

    Time frame: 3 months post operation

07

Study locations

1 of 1 sites recruiting
  • Norwich University Hospitals NHS Foundation Trust
    Norwich, Norfolk NR4 7UY, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07027098
Lead sponsor
Norfolk and Norwich University Hospitals NHS Foundation Trust
Responsible party
Sponsor
First posted
Jun 18, 2025
Start date
Oct 28, 2025
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Apr 14, 2026

Study contacts

Francesco Sabatino
Contact
francesco.sabatino@nnuh.nhs.uk
+441603 286286
Sean Zhou
Contact
Sean.Zhou@nnuh.nhs.uk
+441603 286286
Francesco Sabatino
principal investigator · Norwich University Hospitals NHS Foundation Trust,

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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