Perfluorocarbon liquid during pars plana vitrectomy to reduce retinal vessel displacement after macula-involving retinal detachment
Retinal Displacement After Pars Plana Vitrectomy for Macula Involving Retinal Detachment: A Randomised Prospective Study Evaluating the Role of Intraoperative Perfluorocarbon Liquids
NA · Norfolk and Norwich University Hospitals NHS Foundation Trust · NCT07027098
The team will test whether using perfluorocarbon liquid during vitrectomy reduces retinal shifting and related visual distortion in adults having surgery for macula-off rhegmatogenous retinal detachment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 292 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Norfolk and Norwich University Hospitals NHS Foundation Trust (other) |
| Locations | 1 site (Norwich, Norfolk) |
| Trial ID | NCT07027098 on ClinicalTrials.gov |
What this trial studies
This interventional comparison enrolls adults with primary macula-involving rhegmatogenous retinal detachment who are eligible for pars plana vitrectomy with gas tamponade. Participants will undergo vitrectomy either with intraoperative perfluorocarbon liquid (PFCL) or without PFCL, and retinal position will be documented using wide-field OCT and fundus autofluorescence before and after surgery. The main imaging outcome is retinal vessel displacement (retinal vessel printing) and visual outcomes including best-corrected visual acuity will be recorded. Patient-reported visual symptoms such as metamorphopsia and central scotomas will also be collected during follow-up up to three months.
Who should consider this trial
Good fit: Adults (18+) with primary macula-off rhegmatogenous retinal detachment with posterior vitreous detachment who are eligible for gas tamponade and can complete OCT and FAF imaging and follow-up are ideal candidates.
Not a fit: Patients with macula-on detachments, prior retinal detachment surgery in the study eye, planned silicone oil or scleral buckle use, or other retinal diseases causing permanent structural changes are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative retinal displacement and related visual distortions, improving functional vision after macula-involving retinal detachment surgery.
How similar studies have performed: Perfluorocarbon liquids have been used intraoperatively to flatten the retina and small series suggest they may reduce displacement, but high-quality comparative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Norwich, Norfolk
- Norwich University Hospitals NHS Foundation Trust — Norwich, Norfolk, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Francesco Sabatino — Norwich University Hospitals NHS Foundation Trust,
- Study coordinator: Francesco Sabatino
- Email: francesco.sabatino@nnuh.nhs.uk
- Phone: +441603 286286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinal Displacement After Retinal Detachment Surgery, Retinal displacement, retinal detachment, Heavy liquid, perfluorocarbon liquids