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MQUEST: Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery

Sponsor
Hayley Westwood (Other)
Overall Status
Completed
CT.gov ID
NCT05171621
Collaborator
(none)
50
Enrollment
1
Location
24.5
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessing metamorphopsia and quality of vision pre and post epiretinal and macular hole surgery

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Metamorphopsia is a visual symptom in which straight lines appear distorted, for example a vertical window blind may appear wavy which can affect quality of vision. Metamorphopsia is a common symptom in retinal conditions such as epiretinal membranes (ERM) and macular holes. There is a lack of studies analysing the prevalence of ERM in the UK and Europe.

    Both of the conditions have shown to be a higher risk factor with age. With an aging population it is likely these numbers will increase. Currently the only treatment option is surgery (vitrectomy) or conservative management to monitor the condition. It would therefore be beneficial to find a tool that would inform the surgeon of a patient's quality of vision and how this impacts their life. A patient's severity of metamorphopsia reveals more precise information on the progression of the disease than visual acuity alone (Nomoto et al. 2013) therefore gaining a better understanding can help aid clinical decisions.

    Current clinical practice is to monitor metamorphopsia with an Amsler chart, a grid with lines; the patient is then asked to draw where they can see distortion. They are used to detect metamorphopsia but are unable to quantify and provide an accurate measurement of the severity of metamorphopsia and quality of vision

    The Quality of Vision questionnaire (QoV) (McAlinden et al. 2010) is a modern tool developed to specifically measure subjective quality of vision. The Metamorphopsia questionnaire (Arimura et al. 2011) has been developed to provide a measurement of subjective metamorphopsia in macular disease. Both have been psychometrically validated and are in use in a number of clinical trials worldwide.

    It would be valuable to investigate the role of each questionnaire in identifying quality of vison and metamorphopsia pre- and post-surgery for ERM and macular holes to establish if there are changes to patient responses. We would compare this to visual acuity and optical coherence tomography (OCT) images pre- and post-surgery to see if changes correspond to the questionnaire responses. If a questionnaire can measure metamorphopsia and its impact on quality of vision in ERM and macular holes, this would assist in clinical decision making.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
    Actual Study Start Date :
    Oct 16, 2019
    Actual Primary Completion Date :
    Oct 31, 2021
    Actual Study Completion Date :
    Oct 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Macular holes
    Epiretinal membranes

    Outcome Measures

    Primary Outcome Measures

    1. Compare the responses of the McAllinden and Metamorphopsia Questionnaire [pre surgery and 2 - 3 months post surgery]

      analysing changes to responses in the 2 questionnaires pre and post surgery

    Secondary Outcome Measures

    1. Changes to BCVA score [Pre surgery and 2-3 months post surgery]

      Patients BCVA pre and post surgery to see if there is an improvement

    Other Outcome Measures

    1. Assess correlations between the Mcallinden and Metamorphopsia questionnaire scores and objective clinical parameters [Pre surgery and 2-3 month post surgery]

      do the questionnaires show changes pre and post surgery and do they match clinical outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant is willing and able to give informed consent

    • 18 years old

    • Patients listed for epi retinal and macular hole surgery

    • Patient is able to perform study procedures

    Exclusion Criteria:

    • Patients who are diagnosed with a condition other than epiretinal membrane or macular hole

    • Patients not undergoing epiretinal or macular hole surgery

    • Patients will be excluded if there are any complications within surgery, or undergo any procedures that is not an epiretinal or macular hole surgery (i.e vitrectomy, phacoemulsification (lens extraction) as this can affect visual outcomes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Wales Cardiff United Kingdom cf14 4xw

    Sponsors and Collaborators

    • Hayley Westwood

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hayley Westwood, Senior Clinical Research Officer, University Hospital of Wales
    ClinicalTrials.gov Identifier:
    NCT05171621
    Other Study ID Numbers:
    • 18/NOV/7557
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Dec 29, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vision Disorders
    Retinal Perforations
    Epiretinal Membrane

    Study Results

    No Results Posted as of Dec 29, 2021