Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monofocal Extended Range of Vision (MERoV) Study (MERoV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011696
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 25, 2019
Sponsor:
Collaborators:
King's College London
European Society of Cataract and Refractive Surgeons
Information provided by (Responsible Party):
Brighton and Sussex University Hospitals NHS Trust

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
Pseudophakia Accomodation Aberration, Corneal Wavefront

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 412 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monofocal Extended Range of Vision (MERoV) Study
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : July 3, 2020
Estimated Study Completion Date : July 3, 2020



Primary Outcome Measures :
  1. Uncorrected distance and near vision [ Time Frame: 3 months postoperatively ]
    Uncorrected distance of 20/40 and near of J4


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011696


Contacts
Layout table for location contacts
Contact: Mayank A Nanavaty, FRCOphth,PhD 00441273696955 ext 7652 mayank.nanavaty@nhs.net
Contact: Sean Gallagher, BMedSci 00441273696955 ext 3115 sean.gallagher5@nhs.net

Locations
Layout table for location information
United Kingdom
Mayank Nanavaty Recruiting
Brighton, United Kingdom, BN2 5BF
Contact: Sean Gallagher, BMedSci    00441273696955 ext 3115    sean.gallagher5@nhs.net   
Contact: Maria Wendam, RSN    00441273696955 ext 3115    maria.wendam@nhs.net   
Sponsors and Collaborators
Brighton and Sussex University Hospitals NHS Trust
King's College London
European Society of Cataract and Refractive Surgeons
Investigators
Layout table for investigator information
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
Publications:
Layout table for additonal information
Responsible Party: Brighton and Sussex University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04011696    
Other Study ID Numbers: 264296
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be collected in paper files and NHS computers. No external agency will have access to the study data.

Layout table for additional information
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:
pseudoaccommodation
monofocal IOL
cataract surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Corneal Wavefront Aberration
Pseudophakia
Signs and Symptoms
Corneal Diseases
Eye Diseases
Refractive Errors