Monofocal Extended Range of Vision (MERoV) Study

Sponsor
Brighton and Sussex University Hospitals NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT04011696
Collaborator
King's College London (Other), European Society of Cataract and Refractive Surgeons (Other)
412
1
33
12.5

Study Details

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    412 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Monofocal Extended Range of Vision (MERoV) Study
    Actual Study Start Date :
    Jul 3, 2019
    Anticipated Primary Completion Date :
    Apr 3, 2022
    Anticipated Study Completion Date :
    Apr 3, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Uncorrected distance and near vision [3 months postoperatively]

      Uncorrected distance of 20/40 and near of J4

    Secondary Outcome Measures

    1. Spherical error [3 months postoperatively]

      Spherical error on manifest refraction

    2. astigmatic error [3 months postoperatively]

      astigmatic error on manifest refraction

    3. Pupil size [3 months postoperatively]

      Pupil size in mesopic condition

    4. Total spherical and vertical coma aberrations [3 months postoperatively]

      Total spherical and vertical coma aberrations on aberrometry

    5. Reading speed and critical font size [3 months postoperatively]

      Measured on Salzburg's reading desk

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Mayank Nanavaty Brighton United Kingdom BN2 5BF

    Sponsors and Collaborators

    • Brighton and Sussex University Hospitals NHS Trust
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Brighton and Sussex University Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04011696
    Other Study ID Numbers:
    • 264296
    First Posted:
    Jul 8, 2019
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brighton and Sussex University Hospitals NHS Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2022