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NCT Number: NCT04263636

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phacoemulsification with bilateral trifocal diffractive IOLs

Procedure

Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs

Primary outcomes

  1. Minimum light intensity

    Time frame: 6 months postoperatively

    Minimum light intensity in which participants reach their maximum critical visual acuity

Secondary outcomes

  1. Critical Visual Acuity (CVA)

    Time frame: 6 months postoperatively

    The print size of the optotype line fulfilling this criterion: all of the following lines are read at a time that is 1.96 times the standard deviation over the average reading time of the larger preceding lines. In clinical practice, the CVA is the minimum VA that can be read with the maximum possible speed.

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2020
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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