Monofocal Extended Range of Vision (MERoV) Study

Pseudophakia Clinical Trial

— MERoV  

Official title:

Monofocal Extended Range of Vision (MERoV) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011696
• Other study ID #: 264296
• Status: Completed
• Start date: July 3, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aberration, Corneal Wavefront
• Accomodation
• Corneal Wavefront Aberration
• Pseudophakia

Locations

Country	Name	City	State
United Kingdom	Mayank Nanavaty	Brighton

Sponsors (3)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust	European Society of Cataract and Refractive Surgeons, King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncorrected distance and near vision	Uncorrected distance of 20/40 and near of J4	3 months postoperatively
Secondary	Spherical error	Spherical error on manifest refraction	3 months postoperatively
Secondary	astigmatic error	astigmatic error on manifest refraction	3 months postoperatively
Secondary	Pupil size	Pupil size in mesopic condition	3 months postoperatively
Secondary	Total spherical and vertical coma aberrations	Total spherical and vertical coma aberrations on aberrometry	3 months postoperatively
Secondary	Reading speed and critical font size	Measured on Salzburg's reading desk	3 months postoperatively