Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery

NCT03893838 | Unknown

• 1 other identifier: ST001.2018
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors; Aberration, Corneal Wavefront

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in Hue 100 test

  6 months

• Change of contrast sensitivity for near vision

  6 months

• Visual Function Questionaire 25

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after refractive surgery

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wrocław University of Science and Technology: lead
• Wroclaw Medical University: collaborator

Study Sites (1)

Department of Optics and Photonics

Wroclaw, 50-370, Poland

Location

MeSH Terms

Conditions

Refractive Errors; Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Eye Diseases; Corneal Diseases

Study Officials

• Joanna Przeździecka-Dołyk, PhD

  Wrocław University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 28, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2024
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

PL (1)