A Phase 2 feasibility study published today in the prestigious Nature Communications Medicine journal has shown that early vitrectomy surgery treatment for acute endophthalmitis can be potentially more beneficial to patients’ vision compared with the current antibiotic-first approach.
This is a bacterial infection, affecting the fluid and tissue inside the eye. It is a rare condition (1 in 1000 to 2000 patients), but is a devastating complication from any form of eye surgery or eye injection, and can lead to sight loss and blindness. Treatment guidelines only exist for cataract treatment, and the conventional approach across ophthalmology has been to repeat intravitreal antibiotic injections during the early phase of the condition, then conduct a vitrectomy if this has not proved effective.
Thirty years ago, research indicated the potential benefits of immediate vitrectomy for patients developing endophthalmitis after cataract surgery, but this is seldom carried out. Since then, the development of small gauge (23-, 25 and 27-) pars plana vitrectomy (PPV), wide-angle viewing systems and the routine use of silicone oil have led to a significant evolution for the procedure.
This 21-centre national UK study of 63 patients is the first randomised control trial to evaluate the potential benefits of carrying out the vitrectomy at an early stage, within 48-96 hours of diagnosis of endophthalmitis following any type of invasive eye procedures.
After six months, patients receiving this treatment had a median improvement of 40 letters (range 28-70 letters) compared with those having an initial regime of up to six months of antibiotics (median 13 letters increase in vision, range 0-66 letters). The median improvement for the new approach therefore shows over three times the median sight improvement of the conventional treatment.
Importantly, these improvements came earlier for patients too, bringing relief and recovery from what can be a painful condition as well as removing the psychological shadow of potential sight loss from them sooner. At the six-month cut-off period, this study shows these patients can potentially achieve greater improvements in acuity which, if this endures, further increases thesocial benefit.
Early vitrectomy also showed lower rates of non-serious adverse events (47% vs 68%) and retinal detachment.
The feasibility of the approach and its acceptability to patients and surgeons were validated by the study team.
These promising results are based on a sample of 63 so have relatively low levels of statistical significance, but point to the merits of conducting a larger Phase 3 clinical trial.
Lead author Mahi Muqit, senior vitreoretinal consultant at Moorfields Eye Hospital and associate professor at the Institute of Ophthalmology at UCL, said: “This important new study shows the potential short-term and long-term potential benefits to patients given an early vitrectomy if they contract endophthalmitis after their eye procedure. As using this intervention at diagnosis shows clear potential to improve clinical outcomes, we now intend to take this forward to a definitive Phase 3 randomised clinical trial that can definitively answer this question.”
