Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Refractive Errors; Aberration, Corneal Wavefront

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 50-370
    • Department of Optics and Photonics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients after refractive surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of high order and chromatic aberrations after refractive surgery	number of high order and chromatic aberrations after refractive surgery	6 months
Chromoretinoscopy for near (MEM) and distance	Conducted with a modified by researchers retinoscopy with distinct filters	6 months
Aberrometry reading for corneal HOA	Conducted with aberrometer and corneal tomography	6 months
Transverse chromatic aberration	Conducted with a modified by researchers aniseikonia test (with red and green lenses)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Visual Function Questionaire 25	Conducted with VFQ-25 test	6 months

Collaborators and Investigators

• Sponsor: Wrocław University of Science and Technology
• Collaborators: Wroclaw Medical University
• Investigators: Principal Investigator: Joanna Przeździecka-Dołyk, PhD, Wrocław University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Refractive Errors; Corneal Wavefront Aberration
• Other Study ID Numbers: ST001.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We intend to share anonymised data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No