Open Studies

Full title: Epiretinal membrane and acute Pseudophakic cystoid macular oedema: A prospective multi-centre observational study of Implications and treatment outComes (EPIC)

Summary: Epiretinal membrane and acute Pseudophakic cystoid macular oedema: A prospective multi-centre observational study of Implications and treatment outComes (EPIC)

Cataract surgery is the most frequently performed surgery in the NHS. Cystoid macular oedema (CMO, inflammation and fluid accumulation in the central retina) is the most common visually significant complication following cataract surgery occurring in 1-2% of cases. Many cases resolve with topical anti-inflammatory eye drops. However some cases do not respond and require more invasive treatment modalities eg injections into the eye. If CMO remains persistent this can lead to permanent visual loss. There is little current knowledge on what factors lead to persistence in some cases compared to others. Epiretinal membrane (ERM, a fibrocellular membrane that can form on the inner retina) can be associated with a similar cystoid macular oedema that often does not resolve until the ERM is removed surgically. This study aims to look at whether the presence of an ERM affects how long it takes for cystoid macular oedema to resolve following cataract surgery and the requirement for non-topical treatment modalities.

A prospective, non-interventional, observational study design is proposed. Eligible participants would be identified at one of several participating NHS hospitals in the Wessex Deanery. Subjects with evidence of CMO post-cataract surgery and commenced on treatment would be included. Treatment choice is at the discretion of the reviewing clinician and independent of the study protocol. Investigations performed would be only those conducted as part of standard care. Presence of epiretinal membrane would be determined from review of the medical records. Case-records of eligible participants would be reviewed over a 12-month period to assess response to treatment and type of treatment(s) used. Based on current surgical data recruitment would be estimated to take 18 months to achieve the 165 eligible participants to achieve statistical power.

Prevalence of subclinical Non-Exudative choroidal neovascularisation and its contribution to prediction of exudatiON in fellow eyes with unilateral exudative AMD (EYE-NEON)

Patients with wet age-related macular degeneration (wAMD) in one eye are at risk of developing wAMD in the second “normal” eye (fellow eye) as well. This risk increases yearly and one of the factors among these is presence of inactive wet AMD in the fellow eye (study eye). At present, there is not sufficient knowledge to inform patients how the presence of this inactive disease in the “normal eye” would affect the risk for conversion to wet AMD, which makes counselling patients and planning difficult.

This study will therefore collect coded (pseudoanonymised) retinal images from scans and markers on these retinal image scans will be looked at. The risk of conversion in the “normal eye” to wet AMD will be calculated.

The study will be divided into 2 parts:

1.Prospective: Patients with a new diagnosis of wAMD and started on antiVEGF will consent for the prospective part of the study. Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA) will be used to image the study eye at a baseline visit and then at 1 and 2 years later to identify and study progress of Non-exudative Choroidal Neovascularization (neCNV) to predict increased risk of conversion of inactive wAMD to wAMD.
2. Retrospective: All patients who have started on antiVEGF treatment in one eye with wAMD in the last 12-15 months and the study eye that meet the inclusion and exclusion criteria will also be included in the study for retrospective data collection. Images from scans taken as per standard care will be collected for the study at baseline and year 1 and 2.

The study will run at approximately 25 sites across the UK. Patients will be in the study for 2 years and the study will run for 48 months.