Portsmouth Hospitals Trust
Portsmouth, PO6 3LY, United Kingdom
NCT Number: NCT03965078
This study examines whether the presence of an epiretinal membrane affects the time to resolution, requirement for non-topical treatment, and outcome of pseudophakic cystoid macular oedema.
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Notify Me18 year and older
All sexes
Observational
Portsmouth, PO6 3LY, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participant may not enter the study if there is evidence that macular oedema may have been present pre-operatively. This will include ANY of the following:
Initial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician
Time frame: 1 year
The time to resolution of the CMO will be calculated from the time of commencement of treatment until the documented time of resolution (based on clinical entry and confirmation on OCT scan). The clinical notes will be accessed at 3 months, 6 months and 12 month time-points to extract this data from the intervening clinical visits. The patient will complete the study either once the CMO is determined to have resolved or at 12 months post-commencing treatment, whichever is sooner.
Time frame: 3, 6 and 12 months
Time frame: 12 months
To describe the proportion of CMO patients requiring non-topical treatment, to compare this proportion between patients with and without ERM, and to describe the types of treatment received
Time frame: 12 months
To determine visual outcomes for patients with pseudophakic CMO and to compare these between patients with and without ERM
Portsmouth Hospitals NHS Trust
Other Gov
Epiretinal Membrane and Acute Pseudophakic Cystoid Macular Oedema: A Prospective Multi-centre Observational Study of Implications and Treatment outComes
Acronym: EPIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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