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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263636
• Other study ID #: ES11/Th12/27-12-2019
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Democritus University of Thrace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Procedure:
• Phacoemulsification with bilateral trifocal diffractive IOLs
Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum light intensity	Minimum light intensity in which participants reach their maximum critical visual acuity	6 months postoperatively
Secondary	Critical Visual Acuity (CVA)	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.	6 months postoperatively