Ophthalmology 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.

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.

Sight is considered by many as our most important sense. One part of sight is our field of vision. The normal visual field allows us to look straight ahead at an object but still be visually aware of our surroundings out to the far sides of our vision. After stroke a common problem is ‘hemianopia’ which is loss of one half of the visual field leaving people with a ‘blind’ side to the right or left side of their vision.

Hemianopia occurs suddenly in 30% of stroke survivors with devastating impact on quality of life - individuals cannot drive, have difficulty reading, bump into people and objects, and can lead to a loss of independence, social isolation, falls and depression. It may also affect peoples’ abilities to undertake treatment for other stroke-related problems.

Providing treatment to help stroke patients adapt to their visual field loss is variable and not standardised in the NHS because of uncertainty about what works best and when is the best time to offer treatment. This causes unacceptable inequality in health care. A review of treatment options for hemianopia concluded that visual search training is potentially useful. Visual search training involves repeated practice by the patient at locating different targets on both the seeing and blind sides of their visual field. This training can be provided by many methods – some needing paper cards for the training and others
needing computers. Paper-based visual search training is available to ALL patients whereas computer training is not.

Our VISION ‘pilot’ trial tested how useful a new portable paper-based training was in comparison to prism treatment and no treatment. It provided information on how many patients would take part in a trial, what assessments were important and what people thought of the treatments. We have used the published VISION results to design this new trial.

In this (SEARCH) trial, we aim to find out how effective the paper-based visual search training is for hemianopia after stroke. In a randomised clinical trial 71 people will undertake eye search training for 30 minutes daily, 7 days/week over 6 weeks; 71 people will undertake sham training for 30 minutes, 7 days/week over 6 weeks.. Everyone will be followed for 6 months. We will test peoples’ visual reactions and independence in daily activities and compare groups to see if there is more benefit from search treatment. This trial is important as it addresses an area of treatment for which there is limited evidence and currently no standard care in the NHS. This treatment is a top priority highlighted by 2 national surveys that involved a large number of patients and carers. Despite research results indicating that search and detection of objects in the ‘blind’ side can be improved with training, questions remain about patient benefit from this treatment and cost of treatment. There is limited information on how this type of treatment affects daily life.