Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections

NCT ID: NCT04263636

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-12-31

Brief Summary

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Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.

Detailed Description

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Present study aims to identify in which degree multifocal IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following bilateral pseudophakic presbyopic corrections. Specifically, the aim of this study is to identify the minimum light intensity in which patients that underwent pseudophakic presbyopic correction with trifocal IOLs can reach their maximum visual acuity (measured when lights are at the 100% lighting level)

Conditions

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Presbyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

Patients that underwent uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs (PanOptix or PanOptix toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)

Phacoemulsification with bilateral trifocal diffractive IOLs

Intervention Type PROCEDURE

Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs

Control group

Patients of similar age without cataract that their crystalline lens has not been replaced.

No interventions assigned to this group

Interventions

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Phacoemulsification with bilateral trifocal diffractive IOLs

Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 45 to 70 years

Exclusion Criteria

* astigmatism \>1.00 diopters
* glaucoma
* former incisional eye surgery
* corneal or fundus disease
* diabetes mellitus
* autoimmune diseases
* neurological or psychiatric diseases
* posterior capsule rupture or lens misalignment
* postoperative uncorrected bilateral distant visual acuity \< 8/10.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD, PhD

Role: STUDY_CHAIR

Associate Professor

Locations

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University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

References

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Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.

Reference Type DERIVED
PMID: 34866900 (View on PubMed)

Other Identifiers

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ES11/Th12/27-12-2019

Identifier Type: -

Identifier Source: org_study_id

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