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

• Sponsor: Democritus University of Thrace (Other)
• Overall Status: Completed
• CT.gov ID: NCT04263636
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 11.8
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Procedure: Phacoemulsification with bilateral trifocal diffractive IOLs

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Introduction of a Modified Luminous Efficiency Function V(λ)' That Addresses Total Light Transmittance of Patients That Underwent Pseudophakic Presbyopic Corrections
• Actual Study Start Date: Jan 7, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Study group Patients that underwent uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs (PanOptix or PanOptix toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)	Procedure: Phacoemulsification with bilateral trifocal diffractive IOLs; Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs
Control group Patients of similar age without cataract that their crystalline lens has not been replaced.

Outcome Measures

Primary Outcome Measures

1. Minimum light intensity [6 months postoperatively]

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

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Alexandroupolis	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

• Democritus University of Thrace

Investigators

• Study Chair: Georgios Labiris, MD, PhD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georgios Labiris, Associate Professor of Ophthalmology, Democritus University of Thrace
• ClinicalTrials.gov Identifier: NCT04263636
• Other Study ID Numbers: ES11/Th12/27-12-2019
• First Posted: Feb 11, 2020
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Georgios Labiris, Associate Professor of Ophthalmology, Democritus University of Thrace: pseudophakic presbyopic correction; trifocal intraocular lens; light intensity; eye light transmittance; light efficiency function
• Additional relevant MeSH terms: Presbyopia

Study Results

No Results Posted as of Mar 30, 2021