5 Safety

5 Safety

This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

5.1 All the adverse events presented to the Committee came from a single case series of 30 patients; each affected patient may have experienced more than 1 adverse event.

5.2 Serious retinal complications were reported in 10% (3/30) of patients. A retinal tear was reported in 1 patient (timing not reported and no further details were provided). Rhegmatogenous retinal detachment that needed surgical repair was reported in 1 patient. Tractional retinal detachment was reported in 1 patient at 5‑month follow‑up: the patient had incurred blunt trauma to the eye with the implant, resulting in proliferative vitreoretinopathy that progressed to retinal detachment. This was repaired by vitrectomy, partial retinectomy and silicone oil.

5.3 Replacement of retinal tacks was needed within the first few days of implantation in 7% (2/30) of patients.

5.4 Conjunctival dehiscence was reported in 10% (3/30) of patients. Neither the timing nor the clinical significance of these dehiscences was described. They were treated by additional sutures with or without placement of additional tissue.

5.5 Conjunctival erosion was reported in 7% (2/30) of patients. Timing of occurrence was not reported.

5.6 Presumed endophthalmitis was reported, within 8 weeks of surgery, in 10% (3/30) of patients. This resolved in all cases with antibiotic treatment.

5.7 Hypotony was reported in 10% (3/30) of patients within 1 year of surgery. All cases of hypotony needed surgical treatment: 2 patients needed intraocular silicone tamponades and 1 patient had the implant removed.

5.8 Severe inflammatory uveitis was reported in 1 patient. Timing of occurrence was not reported and no further details were provided.

5.9 Intraocular inflammation, hypotony without choroidal detachment, suture irritation and ocular pain were reported in up to 23% (7/30) of patients. All were reported as non‑severe events. No exact figures were reported, timing of occurrence was not reported, and no further details were provided.

5.10 Inflammatory conjunctivitis, corneal filaments, epiretinal membrane, high intraocular pressure (controlled by anti‑glaucoma medications), epiphora, mild hyphaema, inflammatory uveitis with few keratic precipitates, and mild vitreous haemorrhage were reported in up to 10% (3/30) of patients. All were reported as non‑severe events. No exact figures were reported, timing of occurrence was not reported, and no further details were provided.

5.11 A single occurrence was reported of each of the following: limited conjunctival dehiscence, corneal abrasion, mild peripheral corneal vascularisation, cystoid macular oedema, decrease in light perception, dry eye, transient headache, iris vessel engorgement, stable tractional retinal detachment, transient nausea, transient increased nystagmus, scleritis, and transient vertigo. Each occurrence was considered non‑severe.

5.12 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not highlight any anecdotal adverse events. They considered that the following were theoretical adverse events: loss of residual existing vision, phthisis bulbi, suprachoroidal haemorrhage, secondary neovascularisation, allergic reaction to the implant, failure of the implant, extrusion of the implant, and complications associated with vitrectomies.

  • National Institute for Health and Care Excellence (NICE)