Vitrectomy Clinical Trials

Clinical trials related to Vitrectomy Procedure

Retinal Displacement After Pars Plana Vitrectomy for Macula Involving Retinal Detachment: A Randomised Prospective Study Evaluating the Role of Intraoperative Perfluorocarbon Liquids

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Contact Information
Primary
Francesco Sabatino
francesco.sabatino@nnuh.nhs.uk
+441603 286286
Backup
Sean Zhou
Sean.Zhou@nnuh.nhs.uk
+441603 286286
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 292
Treatments
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.
Active_comparator: Retinal Detachment Surgery (Vitrectomy) Without Perflurocarbon liquid use.
Standard retinal detachment surgery (vitrectomy) without the use of Perflurocarbon liquid (PFCL).
Related Therapeutic Areas
Sponsors
Leads: Norfolk and Norwich University Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov