NCT04011696: MERoV

Monofocal Extended Range of Vision (MERoV) Study

Completed Last updated 3 November 2023

What this trial tests

trial in Pseudophakia in 412 participants. Completed in 31 May 2022.

Timeline

3 July 2019

Primary endpoint
31 May 2022

31 May 2022

Quick facts

Lead sponsor	Brighton and Sussex University Hospitals NHS Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	412
Start date	3 July 2019
Primary completion	31 May 2022
Estimated completion	31 May 2022
Sites	1 location across United Kingdom

Conditions studied

• Pseudophakia — all drugs for Pseudophakia →
• Accomodation — all drugs for Accomodation →
• Aberration, Corneal Wavefront — all drugs for Aberration, Corneal Wavefront →

Sponsor

Brighton and Sussex University Hospitals NHS Trust

Who can join

18 and older, any sex, with Pseudophakia or Accomodation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Incidence and factors for pseudoaccommodation after monofocal lens implantation: the Monofocal Extended Range of Vision study.
   Nanavaty MA, Mukhija R, Ashena Z, Bunce C, et al · · 2023 · cited 9× · PMID 37769187 · DOI 10.1097/j.jcrs.0000000000001302
2. Unaided reading speed in pseudophakic patients after emmetropic monofocal intraocular lens implantation.
   Nanavaty MA, Mukhija R, Ashena Z, Bunce C, et al · · 2025 · PMID 41131330 · DOI 10.1038/s41433-025-04048-x