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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03893838
Other study ID # ST001.2018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date February 1, 2024

Study information

Verified date March 2022
Source Wroclaw University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date February 1, 2024
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Poland Department of Optics and Photonics Wroclaw

Sponsors (2)

Lead Sponsor Collaborator
Wroclaw University of Science and Technology Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of high order and chromatic aberrations after refractive surgery number of high order and chromatic aberrations after refractive surgery 6 months
Primary Chromoretinoscopy for near (MEM) and distance Conducted with a modified by researchers retinoscopy with distinct filters 6 months
Primary Aberrometry reading for corneal HOA Conducted with aberrometer and corneal tomography 6 months
Primary Transverse chromatic aberration Conducted with a modified by researchers aniseikonia test (with red and green lenses) 6 months
Secondary Change in Hue 100 test without and after the introduction of glasses with accommodation support, a blue light filter or concave lenses up to -0,5 diopter 6 months
Secondary Change of contrast sensitivity for near vision without and after the introduction of glasses with accommodation support, a blue light filter or concave lenses up to -0,5 diopter 6 months
Secondary Visual Function Questionaire 25 Conducted with VFQ-25 test 6 months
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