An observational study in Pseudophakia, Accomodation and Aberration, Corneal Wavefront, sponsored by Brighton and Sussex University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.
Sponsored by Brighton and Sussex University Hospitals NHS Trust · Observational
The investigators are proposing this research project to:
Potentially eligible patients will be given an invitation letter and patient information sheet on the day they arrive for surgery. They will then be asked if they are happy to be contacted by phone 2-4 weeks post-surgery with a view to booking them into an additional research visit at 3 months after their surgery. At 3 months after surgery they will have their un-corrected vision checked. They will also have their reading speed assessed without any glasses. They will undergo a through refractive check by an optometrist to assess the power of the spectacles (if needed) and following this they will have a scan of the eye (a technique known as wave front analysis which uses very sophisticated optics) to capture the optical distortions in the structures of the eye.
If this study is able identify factor/s responsible for giving good unaided reading and distance vision then this factor can be reproduced in eyes undergoing cataract surgery. This will mean that the patients can have an increased option of spectacle independence without the need for expensive multifocal IOLs and their associated side effects such as glare and halos, particularly at night.
TYPE OF THE STUDY:
A prospective, non-blinded, non-randomized, single eye cohort study in patients who had uneventful cataract surgery with a monofocal IOL.
Potentially eligible patients will be given an invitation letter and patient information sheet on the day they arrive for surgery. They will then be asked if they are happy to be contacted by phone 2-4 weeks post-surgery with a view to booking them into an additional research visit at 3 months after their surgery.
Inclusion criteria
Exclusion criteria
At 3 months, uniocular unaided distance LogMAR acuity will be recorded. An OCT scan will be performed to establish macular integrity. Pupil size, manifest refraction, measurement of any deviations of the optical rays (called as wavefront aberrometry) will be performed using a iTrace (Tracy Technology) wavefront aberrometer. Unaided reading speed and critical print size will be measured using a Salzberg Reading Desk. Examination time per patient: 40 mins in total. Multivariate statistical analysis will be performed. Power calculation showed a need to examine 412 patients.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 412 is above the median of 71 across 26 observational studies indexed under Pseudophakia.
Browse Pseudophakia studies →Brighton and Sussex University Hospitals NHS Trust is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the purpose of this research, the notes of all the patient undergoing routine NHS cataract surgery will be assessed by the research nurse to see if they have a potential to have 6/12 or better vision after cataract surgery. If so, they will be given an invitation letter and patient information sheet on the day they arrive for surgery. They will then be asked if they are happy to be contacted by phone 2-4 weeks post-surgery with a view to booking them into an additional research visit at 3 months after their surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Uncorrected distance and near vision
Uncorrected distance of 20/40 and near of J4
Time frame: 3 months postoperatively
Spherical error
Spherical error on manifest refraction
Time frame: 3 months postoperatively
astigmatic error
astigmatic error on manifest refraction
Time frame: 3 months postoperatively
Pupil size
Pupil size in mesopic condition
Time frame: 3 months postoperatively
Total spherical and vertical coma aberrations
Total spherical and vertical coma aberrations on aberrometry
Time frame: 3 months postoperatively
Reading speed and critical font size
Measured on Salzburg's reading desk
Time frame: 3 months postoperatively
Plan to share: No — The data will be collected in paper files and NHS computers. No external agency will have access to the study data.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Brighton and Sussex University Hospitals NHS Trust