PseudophakiaMERoVNCT04011696
Monofocal Extended Range of Vision (MERoV) Study
An observational study of Pseudophakia and Accomodation, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The investigators are proposing this research project to: 1. Screen a set of patients after normal cataract surgery with a single focus lens aimed at good distance vision at 3 months after surgery to identify patients who are able to see and read well without glasses. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudophakia, Accomodation, Aberration, Corneal Wavefront
- How many people
- 412 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2019to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Uneventful cataract surgery, sequential recruitment, potential to see 20/40 (6/12) unaided or better postoperatively, no significant macular pathology and willing to follow up at 3 months.
Who cannot join
- Any ocular co-morbidity, which will preclude an expected postoperative 20/40 (6/12) unaided, distance vision. (e.g. amblyopia, corneal pathology, age related macular degeneration, glaucoma, diabetic retinopathy, other previous ocular surgeries), posterior capsule opacification,inability to read English text or physically or mentally unable to and cooperate with the postoperative assessment
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are proposing this research project to:
- Screen a set of patients after normal cataract surgery with a single focus lens aimed at good distance vision at 3 months after surgery to identify patients who are able to see and read well without glasses.
- Identify the combination of factors responsible for this phenomenon in the patients who are achieving this.
Read more
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.
Read the 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
- Uneventful cataract surgery
- Sequential recruitment
- Potential to see 20/40 (6/12) unaided or better postoperatively
- No significant macular pathology
- Willing to follow up at 3 months
Exclusion criteria
- Patients under 20 years of age
- Any ocular co-morbidity, which will preclude an expected postoperative 20/40 (6/12) unaided, distance vision. (e.g. amblyopia, corneal pathology, age related macular degeneration, glaucoma, diabetic retinopathy, other previous ocular surgeries)
- Posterior capsule opacification
- Inability to read English text or physically or mentally unable to cooperate with the postoperative assessment
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.
- Conditions
- Pseudophakia, Accomodation, Aberration, Corneal Wavefront
- Keywords
- pseudoaccommodation, monofocal IOL, cataract surgery
- Medical subject headings
- Pseudophakia, Corneal Wavefront Aberration
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance and near vision
Uncorrected distance of 20/40 and near of J4
Measured: 3 months postoperatively
Secondary outcomes (5)
Spherical error
Spherical error on manifest refraction
Measured: 3 months postoperatively
astigmatic error
astigmatic error on manifest refraction
Measured: 3 months postoperatively
Pupil size
Pupil size in mesopic condition
Measured: 3 months postoperatively
Total spherical and vertical coma aberrations
Total spherical and vertical coma aberrations on aberrometry
Measured: 3 months postoperatively
Reading speed and critical font size
Measured on Salzburg's reading desk
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start3 Jul 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PseudophakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, European Society of Cataract and Refractive Surgeons
- Responsible party
- Sponsor
- Investigators
- Mayank A Nanavaty, FRCOphth,PhD, Study chair, Brighton and Sussex University Hospitals NHS TrustDavid J Spalton, FRCOphth, Principal investigator, King's College LondonCatey Bunce, DSc, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011696
- Sponsor's protocol ID
- 264296
- Acronym
- MERoV
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2019
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be collected in paper files and NHS computers. No external agency will have access to the study data.
Publications
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.
PubMed 16857493Nanavaty 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.
PubMed 19304086Nanavaty 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.
PubMed 20152600Nanavaty 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.
PubMed 37769187
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monofocal Extended Range of Vision (MERoV) Study
- ClinicalTrials.gov ID
- NCT04011696
- Acronym / sponsor ID
- MERoV / 264296
- Conditions
- Pseudophakia, Accomodation, Aberration, Corneal Wavefront
- Keywords
- pseudoaccommodation, monofocal IOL, cataract surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- King's College London, European Society of Cataract and Refractive Surgeons
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are proposing this research project to:
- Screen a set of patients after normal cataract surgery with a single focus lens aimed at good distance vision at 3 months after surgery to identify patients who are able to see and read well without glasses.
- Identify the combination of factors responsible for this phenomenon in the patients who are achieving this.
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.
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
- Uneventful cataract surgery
- Sequential recruitment
- Potential to see 20/40 (6/12) unaided or better postoperatively
- No significant macular pathology
- Willing to follow up at 3 months
Exclusion criteria
- Patients under 20 years of age
- Any ocular co-morbidity, which will preclude an expected postoperative 20/40 (6/12) unaided, distance vision. (e.g. amblyopia, corneal pathology, age related macular degeneration, glaucoma, diabetic retinopathy, other previous ocular surgeries)
- Posterior capsule opacification
- Inability to read English text or physically or mentally unable to cooperate with the postoperative assessment
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Uneventful cataract surgery, sequential recruitment, potential to see 20/40 (6/12) unaided or better postoperatively, no significant macular pathology and willing to follow up at 3 months.
Key exclusion criteria (1 listed)
- Any ocular co-morbidity, which will preclude an expected postoperative 20/40 (6/12) unaided, distance vision. (e.g. amblyopia, corneal pathology, age related macular degeneration, glaucoma, diabetic retinopathy, other previous ocular surgeries), posterior capsule opacification,inability to read English text or physically or mentally unable to and cooperate with the postoperative assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Uncorrected distance and near vision
Time frame: 3 months postoperatively
Uncorrected distance of 20/40 and near of J4
5 secondary outcomes
Spherical error
Time frame: 3 months postoperatively
astigmatic error
Time frame: 3 months postoperatively
Pupil size
Time frame: 3 months postoperatively
Total spherical and vertical coma aberrations
Time frame: 3 months postoperatively
Reading speed and critical font size
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Background: PubMed 16857493Nanavaty 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.
- Background: PubMed 19304086Nanavaty 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.
- Background: PubMed 20152600Nanavaty 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.
- Derived from this study: PubMed 37769187Nanavaty 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayank A Nanavaty, FRCOphth,PhD study chair
Brighton and Sussex University Hospitals NHS Trust
David J Spalton, FRCOphth principal investigator
King's College London
Catey Bunce, DSc principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakia and Accomodation, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected distance and near vision (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011696, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.