Unexplained visual loss following removal of silicone oil

• Research type

  Research Study

• Full title

  Unexplained visual loss following silicone oil removal in patients presenting with retinal detachment in the United Kingdom: results of a prospective surveillance study

• IRAS ID

  229763

• Contact name

  Haifa Madi

• Sponsor organisation

  City Hospital Sunderland NHS Foundation Trust

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  Retinal detachment is a condition where the retina (light sensitive film at the back of the eye) peels away from the inner wall of the eye. The treatment involves surgery to reattach the retina. Silicone oil has an important role in supporting the retina while it heals following surgery for complex retinal detachments. It has the advantage of allowing postoperative assessment and application of laser because of its optical clarity.\n\nRemoval of silicone oil (RoSO) requires another operation and is usually indicated for visual reasons and to reduce the risk of progressive oil-associated complications. Although vision usually improves, mild to moderate visual loss can occur in patients after RoSO, most commonly due to re-detachment, fluid leakage at the back of the eye, loss of eye volume and scar tissue formation. \n\nSeveral case series have reported profound unexplained visual loss following RoSO when no other complications with oil removal are noted and otherwise would have been expected to have good visual outcomes. These reports have been retrospective in nature and only included a small number of cases.\n\nThe aetiology, prevalence and risk factors for this serious complication remain uncertain making counselling patients challenging. Country wide observational data on this phenomenon would enable its natural history to be more clearly defined providing further insight into its cause, prevention and management.\n\nThis study will be carried out using prospective case ascertainment through the British Surveillance Unit (BOSU) monthly reporting card scheme. This is an active surveillance system involving all UK consultant ophthalmologists. This is an epidemiological study using only information available from the patient case notes. Ophthalmologists will indicate that they have seen a new case through the BOSU. The BOSU collects no patient identifying information but will notify the study investigator of all new cases who will contact the reporting ophthalmologist directly.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  17/SW/0289

• Date of REC Opinion

  19 Dec 2017

• REC opinion

  Favourable Opinion