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

Completed

• Conditions: Presbyopia
• Interventions: Procedure: Phacoemulsification with bilateral trifocal diffractive IOLs

• Registration Number: NCT04263636
• Lead Sponsor: Democritus University of Thrace

Brief Summary

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

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)

Study Timeline

• Study Start: 2020-01-07
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-27
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Minimum light intensity	6 months postoperatively	Minimum light intensity in which participants reach their maximum critical visual acuity

Secondary Outcome Measures

Name	Time	Method
Critical Visual Acuity (CVA)	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.

Trial Locations

Locations (1)

University Hospital of Alexandroupolis; 🇬🇷 Alexandroupolis, Evros, Greece