Perceptually Calibrated Scale of Optical Aberrations

NCT05516160 | Unknown

• 1 other identifier: 555
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of the project is to develop a new, more reliable method of modeling and parametrization of the halo and glare phenomena based on the subjective perception of these visual disturbances. The project will consist of three parts. The first will include the psychophysical measurement of glare and halo phenomena perceived by people with multifocal corrective lenses compared to the reference group. The second part will focus on the development of an algorithm for the generation of optical elements (masks) inducing standard halo and glow effects of a given size and intensity. The third phase of the project will concern the calibration of the developed algorithm. For this purpose, the halo and glare will be induced by the developed masks in the healthy eye, so as to match them with the vision disorders measured in the first part of the project in people using multifocal vision correction methods. As a result of this research, a scale for precise measurement of subjective halo and glare phenomena in the field of view will be created, independently covering their intensity and size, and in the future allowing for optical (and not graphic simulation as in commercially available simulators) simulation of scenes seen by patients.

Conditions

Dysphotopsia

Keywords

halo; glare; optical aberrations; multifocal lenses

Outcome Measures

Primary Outcomes (1)

• presence of optical aberrations in analyzed eyes

  halo and glare presence in analyzed eyes

  up to 3 months

Study Arms (2)

multifocal lens

EXPERIMENTAL

examination of dysphotopsia

Diagnostic Test: diagnostic of optical aberrations

control group

ACTIVE COMPARATOR

examination of dysphotopsia

Diagnostic Test: diagnostic of optical aberrations

Interventions

diagnostic of optical aberrations DIAGNOSTIC_TEST

diagnostic of optical aberrations with new device

control group; multifocal lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females, of any race
• one or both eyes with implanted intraocular monofocal lens (10 eyes) and multifocal lens (10 eyes)
• informed consent to participate in the study
• presence at scheduled follow-up visits after the procedure for a period of 24 months.

You may not qualify if:

• in the eye qualified for the test:
• cataract
• Fuchs dystrophy and other corneal diseases
• evidence of serious eye disease
• ophthalmic surgeries other than cataract surgery
• clinically active or past uveitis
• intraocular pressure (IOP) \>21 mmHg
• glaucoma
• retinal detachment or its suspicion in ultrasound examination of the eyeball
• systemic diseases with ocular symptoms, including diseases that may affect the function of corneal endothelial cells
• intolerance of the examination in the slit lamp or other procedures planned in the examination
• pregnancy
• mental disorders or emotional instability to an extent that does not allow the subject's informed consent in the study and presence at scheduled follow-up visits
• documented sensitivity to pharmacological agents used in the study, i.e. topical anesthetics, fluorescein, other related to the ophthalmological examination serious fatal illnesses or a patient's medical condition preventing the study from continuing for a period of 6 months
• current participation in other research programs

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead
• Warsaw University of Technology: collaborator

Related Publications (3)

• Song X, Liu X, Wang W, Zhu Y, Qin Z, Lyu D, Shentu X, Xv W, Chen P, Ke Y. Visual outcome and optical quality after implantation of zonal refractive multifocal and extended-range-of-vision IOLs: a prospective comparison. J Cataract Refract Surg. 2020 Apr;46(4):540-548. doi: 10.1097/j.jcrs.0000000000000088.

  PMID: 32213781 BACKGROUND

• Carson D, Lee S, Alexander E, Wei X, Lee S. Comparison of two laboratory-based systems for evaluation of halos in intraocular lenses. Clin Ophthalmol. 2018 Feb 21;12:385-393. doi: 10.2147/OPTH.S152201. eCollection 2018.

  PMID: 29503526 BACKGROUND

• Savini G, Schiano-Lomoriello D, Balducci N, Barboni P. Visual Performance of a New Extended Depth-of-Focus Intraocular Lens Compared to a Distance-Dominant Diffractive Multifocal Intraocular Lens. J Refract Surg. 2018 Apr 1;34(4):228-235. doi: 10.3928/1081597X-20180125-01.

  PMID: 29634837 BACKGROUND

Study Officials

• Karolina Krix-Jachym, MD PhD

  Military Institute of Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Krix-Jachym, MD PhD

CONTACT

+48602707515; kkrix-jachym@wim.mil.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: August 25, 2022
• Study Start: September 9, 2022
• Primary Completion: December 29, 2022
• Study Completion: December 30, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08