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| Name | Class |
|---|---|
| King's College London | OTHER |
| European Society of Cataract and Refractive Surgeons | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected distance and near vision | Uncorrected distance of 20/40 and near of J4 | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Spherical error | Spherical error on manifest refraction | 3 months postoperatively |
| astigmatic error | astigmatic error on manifest refraction |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Mayank A Nanavaty, FRCOphth,PhD | Brighton and Sussex University Hospitals NHS Trust | Study Chair |
| David J Spalton, FRCOphth | King's College London | Principal Investigator |
| Catey Bunce, DSc | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayank Nanavaty | Brighton | BN2 5BF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16857493 | Background | Nanavaty MA, Vasavada AR, Patel AS, Raj SM, Desai TH. Analysis of patients with good uncorrected distance and near vision after monofocal intraocular lens implantation. J Cataract Refract Surg. 2006 Jul;32(7):1091-7. doi: 10.1016/j.jcrs.2006.03.021. | |
| 19304086 | Background | Nanavaty MA, Spalton DJ, Boyce J, Saha S, Marshall J. Wavefront aberrations, depth of focus, and contrast sensitivity with aspheric and spherical intraocular lenses: fellow-eye study. J Cataract Refract Surg. 2009 Apr;35(4):663-71. doi: 10.1016/j.jcrs.2008.12.011. |
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The data will be collected in paper files and NHS computers. No external agency will have access to the study data.
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| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| D057108 | Corneal Wavefront Aberration |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| 3 months postoperatively |
| Pupil size | Pupil size in mesopic condition | 3 months postoperatively |
| Total spherical and vertical coma aberrations | Total spherical and vertical coma aberrations on aberrometry | 3 months postoperatively |
| Reading speed and critical font size | Measured on Salzburg's reading desk | 3 months postoperatively |
| 20152600 | Background | Nanavaty MA, Spalton DJ, Marshall J. Effect of intraocular lens asphericity on vertical coma aberration. J Cataract Refract Surg. 2010 Feb;36(2):215-21. doi: 10.1016/j.jcrs.2009.08.024. |
| 37769187 | Derived | Nanavaty MA, Mukhija R, Ashena Z, Bunce C, Spalton DJ. Incidence and factors for pseudoaccommodation after monofocal lens implantation: the Monofocal Extended Range of Vision study. J Cataract Refract Surg. 2023 Dec 1;49(12):1229-1235. doi: 10.1097/j.jcrs.0000000000001302. |
| D012030 | Refractive Errors |