Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery

Refractive Errors Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03893838
• Other study ID #: ST001.2018
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aberration, Corneal Wavefront
• Corneal Wavefront Aberration
• Refractive Errors

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