Monofocal Extended Range of Vision (MERoV) Study

NCT04011696 | Completed DMC

• 1 other identifier: 264296
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are proposing this research project to:

1. 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. 2.Identify the combination of factors responsible for this phenomenon in the patients who are achieving this.

Conditions

Pseudophakia; Accomodation; Aberration, Corneal Wavefront

Keywords

pseudoaccommodation; monofocal IOL; cataract surgery

Outcome Measures

Primary Outcomes (1)

• Uncorrected distance and near vision

  Uncorrected distance of 20/40 and near of J4

  3 months postoperatively

Secondary Outcomes (5)

• Spherical error

  3 months postoperatively

• astigmatic error

  3 months postoperatively

• Pupil size

  3 months postoperatively

• Total spherical and vertical coma aberrations

  3 months postoperatively

• Reading speed and critical font size

  3 months postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brighton and Sussex University Hospitals NHS Trust: lead
• King's College London: collaborator
• European Society of Cataract and Refractive Surgeons: collaborator

Study Sites (1)

Mayank Nanavaty

Brighton, BN2 5BF, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 16857493 BACKGROUND

• 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.

  PMID: 19304086 BACKGROUND

• 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.

  PMID: 20152600 BACKGROUND

• Nanavaty 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.

  PMID: 37769187 DERIVED

MeSH Terms

Conditions

Pseudophakia; Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Corneal Diseases; Eye Diseases; Refractive Errors

Study Officials

• Mayank A Nanavaty, FRCOphth,PhD

  Brighton and Sussex University Hospitals NHS Trust

  STUDY CHAIR

• David J Spalton, FRCOphth

  King's College London

  PRINCIPAL INVESTIGATOR

• Catey Bunce, DSc

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 8, 2019
• Study Start: July 3, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)