Postoperative bacterial endophthalmitis is an infection of the eye's internal tissues resulting from an intraocular procedure. The condition is uncommon but can cause severe and irreversible impairment of sight. Standard management involves administration of antibiotics with or without subsequent removal of the infected vitreous gel by vitrectomy surgery. Surgical intervention is typically reserved for infections that persist despite a period of medical management alone. We aim to determine whether outcomes can be improved by performing surgery without delay. To explore the feasibility of a definitive randomised controlled trial and to determine the number of participants required, we will conduct a multicentre feasibility trial. This trial will include 40 affected individuals, allocated randomly to either standard of care, being intravitreal antibiotic administration alone, or to early vitrectomy surgery in addition to antibiotic administration. We will determine the feasibility and size of a definitive trial by evaluating the participants and the outcomes for their sight. Research Ethics Committee approval (REC 20/WM/0264). Here we describe the trial protocol. Trial registration number:ClinicalTrials.gov NCT04522661.
Keywords: Endophthalmitis; vitrectomy; intravitreal antibiotics; randomised controlled trial; visual acuity; complications.
This study aims to assess the feasibility of a trial to determine the benefit of prompt surgery for “endophthalmitis”, which is a rare but blinding eye infection resulting from invasive eye procedures. Endophthalmitis can cause rapidly progressive, severe pain and irreversible loss of sight. Antibiotic administration alone may be insufficient to control the infection and in up to 50% of cases surgery is subsequently performed to improve the outcome by removing the infected vitreous gel (vitrectomy). Usual care involves intensive and extended inpatient and outpatient management over a 6-month period in specialist tertiary centres at considerable cost to the NHS. Surgical intervention is typically reserved for infections that persist despite a period of medical management with intravitreal antibiotics alone. We aim to determine whether outcomes can be improved by performing surgery to remove infected vitreous gel without delay by removing infected vitreous material at the first opportunity. Early vitrectomy surgery has the potential to improve the outcome for people's sight and well-being, and to reduce the associated financial costs to the NHS, and assist in endeavours to reduce antibiotic usage. To find out if earlier surgery can improve the outcome, we first need to determine if an appropriate clinical trial is feasible and decide how it should best be designed. Postoperative endophthalmitis is typically unexpected, causes considerable distress and places demand on urgent clinical services. We need to confirm that a sufficient number of affected people would be willing to participate in such a trial and that the hospitals providing care would have the capacity to perform early surgery. Participants will be randomly allocated to vitrectomy performed at an earlier stage of the condition, or later if needs be in accordance with standard care. Standard follow-up for both arms will continue for a six-month period.
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