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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perflurocarbon liquid

    Procedure/Surgery

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

  • Without Perflurocarbon liquid

    Procedure/Surgery

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

Treatment groups

292 Participants
are divided into 2 treatment groups
Group A: Retinal Detachment Surgery (Vitrectomy) With Perflurocarbon liquid use.Experimental treatment 1 intervention
Group B: Retinal Detachment Surgery (Vitrectomy) Without Perflurocarbon liquid use.Active comparator 1 intervention

Trial outcomes

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

Other outcomes

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