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Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery

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ClinicalTrials.gov Identifier: NCT03893838
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Wroclaw Medical University
Information provided by (Responsible Party):
Wrocław University of Science and Technology

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
Refractive Errors Aberration, Corneal Wavefront

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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 : February 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2024

Group/Cohort
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:

  1. the high order aberrations such as glare, halo and starburst but with the chromatic aureola
  2. difficulties working with LCD projectors, monitors, cell phones and tablets



Primary Outcome Measures :
  1. number of high order and chromatic aberrations after refractive surgery [ Time Frame: 6 months ]
    number of high order and chromatic aberrations after refractive surgery

  2. Chromoretinoscopy for near (MEM) and distance [ Time Frame: 6 months ]
    Conducted with a modified by researchers retinoscopy with distinct filters

  3. Aberrometry reading for corneal HOA [ Time Frame: 6 months ]
    Conducted with aberrometer and corneal tomography

  4. Transverse chromatic aberration [ Time Frame: 6 months ]
    Conducted with a modified by researchers aniseikonia test (with red and green lenses)


Secondary Outcome Measures :
  1. Change in Hue 100 test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    Conducted with VFQ-25 test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients after refractive surgery
Criteria

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

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): NCT03893838


Contacts
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Contact: Joanna Przeździecka-Dołyk, PhD +48605693022 joanna.przezdziecka-dolyk@pwr.edu.pl

Locations
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Poland
Department of Optics and Photonics Recruiting
Wrocław, Poland, 50-370
Contact: Joanna Przeździecka-Dołyk, PhD         
Sponsors and Collaborators
Wrocław University of Science and Technology
Wroclaw Medical University
Investigators
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Principal Investigator: Joanna Przeździecka-Dołyk, PhD Wrocław University of Science and Technology

Additional Information:

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Responsible Party: Wrocław University of Science and Technology
ClinicalTrials.gov Identifier: NCT03893838     History of Changes
Other Study ID Numbers: ST001.2018
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We intend to share anonymised data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Refractive Errors
Corneal Wavefront Aberration
Eye Diseases
Corneal Diseases