Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery

Sponsor
Wrocław University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03893838
Collaborator
Wroclaw Medical University (Other)
100
1
60
1.7

Study Details

Study Description

Brief Summary

Refractive surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. In the proposed protocol focus is on the corneal refractive surgeries impact on monochromatic higher-order aberrations on the one hand and chromatic aberrations on the other. During the surgery in order to get the patient emmetropic, refractive surgery corrects optical defects by decreasing aberrations of lower orders ) simultaneously increases high-order aberrations (that is perceived by the patient as halo, glare or starburst). Informations about prevalence and causes of higher order aberrations after refractive surgery are numerous but there is no information about chromatic aberrations.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery - Preliminary Study Assessing Their Prevalence, Methods of Reductions of Symptoms and Time-dependent Changes in Patients Symptoms
    Actual Study Start Date :
    Feb 1, 2019
    Actual Primary Completion Date :
    Feb 1, 2022
    Anticipated Study Completion Date :
    Feb 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Post refractive surgery without HOA

    Patients post refractive surgery that do not complain on the high order aberrations such as glare, halo and starburst.

    Post refractive surgery with HOA

    Patients post refractive surgery that do complain on the high order aberrations such as glare, halo and starburst.

    Post refractive surgery with rainbow HOA

    Patients post refractive surgery that do complain on: the high order aberrations such as glare, halo and starburst but with the chromatic aureola difficulties working with LCD projectors, monitors, cell phones and tablets

    Outcome Measures

    Primary Outcome Measures

    1. number of high order and chromatic aberrations after refractive surgery [6 months]

      number of high order and chromatic aberrations after refractive surgery

    2. Chromoretinoscopy for near (MEM) and distance [6 months]

      Conducted with a modified by researchers retinoscopy with distinct filters

    3. Aberrometry reading for corneal HOA [6 months]

      Conducted with aberrometer and corneal tomography

    4. Transverse chromatic aberration [6 months]

      Conducted with a modified by researchers aniseikonia test (with red and green lenses)

    Secondary Outcome Measures

    1. Change in Hue 100 test [6 months]

      without and after the introduction of glasses with accommodation support, a blue light filter or concave lenses up to -0,5 diopter

    2. Change of contrast sensitivity for near vision [6 months]

      without and after the introduction of glasses with accommodation support, a blue light filter or concave lenses up to -0,5 diopter

    3. Visual Function Questionaire 25 [6 months]

      Conducted with VFQ-25 test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patient after corneal refractive surgery at least for 4 months

    • post surgical refraction within +/- 0.75 diopter of spherical and +/- 1.0 diopter of cylindrical error

    • willing and able to understand and sign an informed consent form.

    Exclusion Criteria:
    • patient unable to participate in the study

    • any corneal diseases, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus

    • corneal macula and obvious pannus; current enrolment in another clinical trial/research project

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Optics and Photonics Wrocław Poland 50-370

    Sponsors and Collaborators

    • Wrocław University of Science and Technology
    • Wroclaw Medical University

    Investigators

    • Principal Investigator: Joanna Przeździecka-Dołyk, PhD, Wrocław University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wrocław University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT03893838
    Other Study ID Numbers:
    • ST001.2018
    First Posted:
    Mar 28, 2019
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022