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.
Condition or disease |
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Pseudophakia Accomodation Aberration, Corneal Wavefront |
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.
Study Type : | Observational |
Estimated Enrollment : | 412 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Monofocal Extended Range of Vision (MERoV) Study |
Actual Study Start Date : | July 3, 2019 |
Estimated Primary Completion Date : | July 3, 2020 |
Estimated Study Completion Date : | July 3, 2020 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mayank A Nanavaty, FRCOphth,PhD | 00441273696955 ext 7652 | mayank.nanavaty@nhs.net | |
Contact: Sean Gallagher, BMedSci | 00441273696955 ext 3115 | sean.gallagher5@nhs.net |
United Kingdom | |
Mayank Nanavaty | Recruiting |
Brighton, United Kingdom, BN2 5BF | |
Contact: Sean Gallagher, BMedSci 00441273696955 ext 3115 sean.gallagher5@nhs.net | |
Contact: Maria Wendam, RSN 00441273696955 ext 3115 maria.wendam@nhs.net |
Study Chair: | Mayank A Nanavaty, FRCOphth,PhD | Brighton and Sussex University Hospitals NHS Trust | |
Principal Investigator: | David J Spalton, FRCOphth | King's College London | |
Principal Investigator: | Catey Bunce, DSc | King's College London |
Tracking Information | ||||||||||
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First Submitted Date | July 4, 2019 | |||||||||
First Posted Date | July 8, 2019 | |||||||||
Last Update Posted Date | October 25, 2019 | |||||||||
Actual Study Start Date | July 3, 2019 | |||||||||
Estimated Primary Completion Date | July 3, 2020 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures |
Uncorrected distance and near vision [ Time Frame: 3 months postoperatively ] Uncorrected distance of 20/40 and near of J4
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Original Primary Outcome Measures | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title | Monofocal Extended Range of Vision (MERoV) Study | |||||||||
Official Title | Monofocal Extended Range of Vision (MERoV) Study | |||||||||
Brief Summary |
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. |
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Detailed Description |
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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Study Type | Observational | |||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||||||||
Biospecimen | Not Provided | |||||||||
Sampling Method | Non-Probability Sample | |||||||||
Study Population | 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 | |||||||||
Condition |
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Intervention | Not Provided | |||||||||
Study Groups/Cohorts | Not Provided | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status | Recruiting | |||||||||
Estimated Enrollment |
412 | |||||||||
Original Estimated Enrollment | Same as current | |||||||||
Estimated Study Completion Date | July 3, 2020 | |||||||||
Estimated Primary Completion Date | July 3, 2020 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers | Not Provided | |||||||||
Contacts |
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Listed Location Countries | United Kingdom | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number | NCT04011696 | |||||||||
Other Study ID Numbers | 264296 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Brighton and Sussex University Hospitals NHS Trust | |||||||||
Study Sponsor | Brighton and Sussex University Hospitals NHS Trust | |||||||||
Collaborators |
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Investigators |
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PRS Account | Brighton and Sussex University Hospitals NHS Trust | |||||||||
Verification Date | July 2019 |