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

D

Democritus University of Thrace

Status

Not yet enrolling

Conditions

Presbyopia

Treatments

Procedure: Phacoemulsification with EDOF IOLs

Study type

Observational

Funder types

Other

Identifiers

NCT07077967
ES5/Th9/13-02-2025

Details and patient eligibility

About

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.

Full description

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)

Enrollment

100 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Study group
Description:
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)
Treatment:
Procedure: Phacoemulsification with EDOF IOLs
Control group
Description:
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)

Trial contacts and locations

1

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Central trial contact

Georgios Labiris, MD, Prof; Eirini - Kanella Panagiotopoulou, MD, MSc, PhD

Data sourced from clinicaltrials.gov

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