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

NCT ID: NCT07077967

Last Updated: 2025-07-22

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

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-12-15

Brief Summary

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Primary objective of this study is to introduce a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients who underwent pseudophakic presbyopic correction with extended-depth of focus (EDOF) intraocular lenses (IOLs) implantations.

Detailed Description

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Present study aims to identify in which degree EDOF IOLs modify eye light transmission and estimate the necessary task and environmental lighting adjustment in order to address lighting needs of patients following pseudophakic presbyopic corrections implanted with EDOF IOLs. Specifically, the aim of this study is to identify the minimum light intensity at which patients who underwent pseudophakic presbyopic correction with EDOF 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 who underwent uneventful pseudophakic presbyopic correction with yellow filter extended depth-of-focus (EDOF) IOLs (Vivity or Vivity toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)

Phacoemulsification with EDOF IOLs

Intervention Type PROCEDURE

Uneventful pseudophakic presbyopic correction with EDOF IOLs

Control group

Patients of similar age who underwent uneventful cataract surgery implanted with yellow filter monofocal or monofocal toric IOLs (SN60WF or SN6ATx, Alcon Laboratories, Inc., Fort Worth, TX, USA)

No interventions assigned to this group

Interventions

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Phacoemulsification with EDOF IOLs

Uneventful pseudophakic presbyopic correction with EDOF IOLs

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 45 to 75 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 distance visual acuity \< 8/10.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 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

Locations

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University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

Central Contacts

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Eirini - Kanella Panagiotopoulou, MD, MSc, PhD

Role: CONTACT

+30 6978730858

Georgios Labiris, MD, Prof

Role: CONTACT

+30 2551030990

Facility Contacts

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Dimitrios Aggelonias, MSc

Role: primary

+30 2551030990

Eirini - Kanella Panagiotopoulou

Role: backup

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 BACKGROUND
PMID: 34866900 (View on PubMed)

Other Identifiers

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ES5/Th9/13-02-2025

Identifier Type: -

Identifier Source: org_study_id

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