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出境医 / 临床实验 / Monofocal Extended Range of Vision (MERoV) Study (MERoV)

Monofocal Extended Range of Vision (MERoV) Study (MERoV)

Study Description
Brief 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. 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.


Condition or disease
Pseudophakia Accomodation Aberration, Corneal Wavefront

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

  1. Uneventful cataract surgery
  2. Sequential recruitment
  3. Potential to see 20/40 (6/12) unaided or better postoperatively
  4. No significant macular pathology
  5. Willing to follow up at 3 months

Exclusion criteria

  1. Patients under 20 years of age
  2. 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)
  3. Posterior capsule opacification
  4. 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
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Uncorrected distance and near vision [ Time Frame: 3 months postoperatively ]
    Uncorrected distance of 20/40 and near of J4


Secondary Outcome Measures :
  1. Spherical error [ Time Frame: 3 months postoperatively ]
    Spherical error on manifest refraction

  2. astigmatic error [ Time Frame: 3 months postoperatively ]
    astigmatic error on manifest refraction

  3. Pupil size [ Time Frame: 3 months postoperatively ]
    Pupil size in mesopic condition

  4. Total spherical and vertical coma aberrations [ Time Frame: 3 months postoperatively ]
    Total spherical and vertical coma aberrations on aberrometry

  5. Reading speed and critical font size [ Time Frame: 3 months postoperatively ]
    Measured on Salzburg's reading desk


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mayank A Nanavaty, FRCOphth,PhD 00441273696955 ext 7652 mayank.nanavaty@nhs.net
Contact: Sean Gallagher, BMedSci 00441273696955 ext 3115 sean.gallagher5@nhs.net

Locations
Layout table for location information
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   
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
King's College London
European Society of Cataract and Refractive Surgeons
Investigators
Layout table for investigator information
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
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
 (submitted: July 5, 2019)
Uncorrected distance and near vision [ Time Frame: 3 months postoperatively ]
Uncorrected distance of 20/40 and near of J4
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 5, 2019)
  • Spherical error [ Time Frame: 3 months postoperatively ]
    Spherical error on manifest refraction
  • astigmatic error [ Time Frame: 3 months postoperatively ]
    astigmatic error on manifest refraction
  • Pupil size [ Time Frame: 3 months postoperatively ]
    Pupil size in mesopic condition
  • Total spherical and vertical coma aberrations [ Time Frame: 3 months postoperatively ]
    Total spherical and vertical coma aberrations on aberrometry
  • Reading speed and critical font size [ Time Frame: 3 months postoperatively ]
    Measured on Salzburg's reading desk
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:

  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. 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

  1. Uneventful cataract surgery
  2. Sequential recruitment
  3. Potential to see 20/40 (6/12) unaided or better postoperatively
  4. No significant macular pathology
  5. Willing to follow up at 3 months

Exclusion criteria

  1. Patients under 20 years of age
  2. 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)
  3. Posterior capsule opacification
  4. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • Pseudophakia
  • Accomodation
  • Aberration, Corneal Wavefront
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 5, 2019)
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:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mayank A Nanavaty, FRCOphth,PhD 00441273696955 ext 7652 mayank.nanavaty@nhs.net
Contact: Sean Gallagher, BMedSci 00441273696955 ext 3115 sean.gallagher5@nhs.net
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The data will be collected in paper files and NHS computers. No external agency will have access to the study data.
Responsible Party Brighton and Sussex University Hospitals NHS Trust
Study Sponsor Brighton and Sussex University Hospitals NHS Trust
Collaborators
  • King's College London
  • European Society of Cataract and Refractive Surgeons
Investigators
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
PRS Account Brighton and Sussex University Hospitals NHS Trust
Verification Date July 2019

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