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NDys: Characterization and Causative Factors of Negative Dysphotopsia

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Unknown status
CT.gov ID
NCT04224129
Collaborator
(none)
10
Enrollment
1
Location
64
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Defining and Quantifying Negative Dysphotopsia Characterization and Causative Factors of Negative Dysphotopsia
    Study Start Date :
    Jan 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    May 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Identification of factors or a combination thereof that may cause negative dysphotopsia [2 hours]

      Biometry, Anamnesis, visual field, psychological questionnaires, wavefront aberrometry will be used to analyse if a factor causative for negative dysphotopsia can be detected

    Secondary Outcome Measures

    1. Method to standardize characterization of negative dysphotopsia [20 minutes]

      New approaches like Goldmann visual field are used to try to picture negative dysphotopsias and patients will also be asked to draw the "dark shadows"

    2. Correlation between eye biometry, patient complaints and psychophysics [30 minutes]

      Eye biometry will be measured using IOL Master 700, patient complaints will be asked during an patient-doctor interview, and psychophysics will be assessed using a psychological questionnaire

    Eligibility Criteria

    Criteria

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

    • Pseudophakic

    • Recurrently and persistently reporting about negative dysphotopsia

    • Age 21 and older

    • written informed consent prior to entering the study

    Exclusion Criteria:

    • Relevant ophthalmic diseases such as: glaucoma, (previous) traumatic cataract, corneal scars, age-related macular degeneration and other pathologies resulting in visual field defects

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hanusch-Krankenhaus Vienna Austria A-1140

    Sponsors and Collaborators

    • Vienna Institute for Research in Ocular Surgery

    Investigators

    • Principal Investigator: Oliver Findl, MD, Prof., Vienna Institute for Research in Ocular Surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
    ClinicalTrials.gov Identifier:
    NCT04224129
    Other Study ID Numbers:
    • NDys
    First Posted:
    Jan 13, 2020
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Jan 13, 2020