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

NCT07027098 | Recruiting DMC

• 1 other identifier: 327806 (129-06-23)
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinal Displacement After Retinal Detachment Surgery

Keywords

Retinal displacement; retinal detachment; Heavy liquid; perfluorocarbon liquids

Outcome Measures

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.

  3 months post operation

Secondary Outcomes (3)

• Best-Corrected Visual Acuity

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

• Metamorphopsia

  3 months post operation

• Quantification of retinal displacement

  3 months post operation

Study Arms (2)

Retinal Detachment Surgery (Vitrectomy) With Perflurocarbon liquid use.

EXPERIMENTAL

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

Retinal Detachment Surgery (Vitrectomy) Without Perflurocarbon liquid use.

ACTIVE COMPARATOR

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

Procedure: Without Perflurocarbon liquid

Interventions

Perflurocarbon liquid PROCEDURE

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

Retinal Detachment Surgery (Vitrectomy) With Perflurocarbon liquid use.

Without Perflurocarbon liquid PROCEDURE

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

Retinal Detachment Surgery (Vitrectomy) Without Perflurocarbon liquid use.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Francesco Sabatino

  Norwich University Hospitals NHS Foundation Trust,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Sabatino

CONTACT

+441603 286286; francesco.sabatino@nnuh.nhs.uk

Sean Zhou

CONTACT

+441603 286286; Sean.Zhou@nnuh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be masked to the surgical arm they are placed in, as will the investigators examining for retinal displacement (primary outcome).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is designed as a double-blind parallel arm randomised control trial. The trial is designed to show superiority regarding the use of PFCL intraoperatively as compared to without, when relevant to outcomes such as retinal displacement. It will be double blind because neither the participants nor the researchers assessing the outcomes will know what treatment each participant received; the surgeons providing treatment will unavoidably know this.

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: June 18, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

GB (1)