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Completed

NCT Number: NCT04011696

Monofocal Extended Range of Vision (MERoV) Study

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.

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Key information

Conditions

Pseudophakia Aberration, Corneal Wavefront Accomodation Corneal Diseases Corneal Wavefront Aberration Eye Diseases Pathological Conditions, Signs and Symptoms Refractive Errors Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayank Nanavaty

Brighton, BN2 5BF, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Uncorrected distance and near vision

    Time frame: 3 months postoperatively

    Uncorrected distance of 20/40 and near of J4

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust

Other

Collaborators

  • European Society of Cataract and Refractive Surgeons
  • King's College London

Registry information

Acronym: MERoV

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2019
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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