Assessment of Visual and Optical Performance of Intraocular Lenses
Research type
Research Study
Full title
Evaluating the subjective and objective performance of instrumentation used and intraocular devices implanted during routine ocular surgery
IRAS ID
148122
Contact name
James Wolffsohn
Contact email
Sponsor organisation
Aston University
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 11 months, 29 days
Research summary
The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques.
Information sheets will be given to patients who are listed for or have had cataract surgery and intraocular lens implantation at one of the named NHS or private sites. They will have at least 24 hours to decide whether they want to take part in the study. For those confirming they wish to take part, written informed consent will be collected. They will be given manufacturer's information for the lens they will be implanted with or randomised between. They will also have an opportuinity to talk to a surgeon about the lens options and their advantages and disadvantages.
A variety of assessments of visual function, including refraction, acuity testing and imaging techniques, which do not require a patient response, will be carried out pre- and post-operatively and at each subsequent study visit. The visits will be limited to around one hour duration and the assessments will be conducted over the first week, first month, 3 months, 6 months, 12 months and up to 10 years after intraocular lens implantation.
The objective and subjective outcome parameters for each intraocular lens design studied will be analysed and used to evaluate its efficacy.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/1240
Date of REC Opinion
13 Jan 2015
REC opinion
Further Information Favourable Opinion