Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Procedure: Phaco / Panoptix

Detailed Description

Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandroúpoli, Evros, Greece, 68100
      • Democritus University of Thrace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Presbyopia

Exclusion Criteria:

Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Panoptix Group; Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)	Procedure: Phaco / Panoptix; Phacoemulsification with bilateral diffractive trifocal lens implantation
NO_INTERVENTION: Control Group; Control, age-matched presbyopic group corrected with presbyopic glasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
uNVC (3000K)	Uncorrected Near Vision Capacity at 3000 Kelvins	6 months
uNVC (4000K)	Uncorrected Near Vision Capacity at 4000 Kelvins	6 months
uNVC (6000K)	Uncorrected Near Vision Capacity at 6000 Kelvins	6 months
uNVC (25FC)	Uncorrected Near Vision Capacity at 25 Foot Candles	6 months
uNVC (50FC)	Uncorrected Near Vision Capacity at 50 Foot Candles	6 months
uNVC (75FC)	Uncorrected Near Vision Capacity at 75 Foot Candles	6 months

Collaborators and Investigators

• Sponsor: Democritus University of Thrace
• Investigators: Principal Investigator: Georgios Labiris, MD, PhD, Associate professor

Publications and helpful links

General Publications

• Labiris G, Ntonti P, Panagiotopoulou EK, Konstantinidis A, Gkika M, Dardabounis D, Perente I, Sideroudi H. Impact of light conditions on reading ability following multifocal pseudophakic corrections. Clin Ophthalmol. 2018 Dec 14;12:2639-2646. doi: 10.2147/OPTH.S180766. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 334/20-7-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No