Patient reported quality of vision in pseudophakic macular oedema
Research type
Research Study
Full title
Patient reported quality of vision in clinically significant pseudophakic macular oedema
IRAS ID
244708
Contact name
Harry Roberts
Contact email
Sponsor organisation
West Suffolk Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
From June 2016 until January 2018 all cases of the most common complication of cataract surgery, clinically significant macular oedema (CMO), have been identified. These individuals will be contacted by post to establish if they would be interested in participating the study. The volunteers will be sent a participant information sheet, consent forms, a stamped addressed return envelope, and a novel questionnaire for assessing patient reported outcomes for visual acuity, the Cat-PROM5 form. They will then complete this and the consent forms if they choose to participate and post to the Eye Treatment Centre.
The same process will be conducted to recruit twice the number of age, sex and risk factor matched controls who underwent cataract surgery during the same time period.
All participants GPs, with the participant's consent, will be sent a letter informing them of their patient's participation.
Once all the Cat-PROM5’s have been collated and documented the outcomes reported by those patients who had CMO as a result of surgery can be compared to those of the patients who underwent uncomplicated cataract surgery. The outcomes of Cat-PROM5 result in a numerical value for each outcome field assessed. These will be compared using appropriate statistical analyses to assess the hypothesis that there is no difference in patient reported visual outcome between those with uncomplicated cataract surgery and those with CMO as a complication. The study population and the control population will also be compared to check there is no difference in their underlying demographics. Further analysis will also include the clinical outcomes for visual acuity measured in clinic during previous clinical appointments, including accounting for and analysing any underlying risk factors for CMO.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0157
Date of REC Opinion
13 Jun 2018
REC opinion
Further Information Favourable Opinion