Assessment of Near Vision Capacity in Different Light Intensities

Assessment of Near Vision Capacity in Different Light Intensities and Temperatures in Patients Who Underwent Pseudophakic Presbyopic Correction

Patients who underwent presbyopic correction with bilateral bifocal 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 oa patients who underwent presbyopic correction with bilateral bifocal intraocular lenses implantation

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Procedure: BB-Phaco

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral bifocal intraocular lenses implantation

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SG; Study group (patients who underwent pseudophakic presbyopic correction with bilateral bifocal lenses implantation	Procedure: BB-Phaco; Phacoemulsification with bilateral bifocal lenses implantation
CG; Control group (age-matched participants without pseudophakic presbyopic correction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Near Vision Acuity (UnVA)	Near Vision Acuity	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Vision Capacity (NVC)	NVC score will be measured by the performance score in the following ADLs: a) cellular phone directory entry search, b) reading of message in a cellular phone, c) reading a medical prescription, d) reading a public phonebook	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: January 14, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 18, 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: 300/13-1/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO