Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction

Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses

Patients who underwent bilateral bifocal or trifocal lenses implantation for presbyopia correction with monofocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require: a) distant vision (DV), (ie. driving), b) intermediate vision (IV), (ie. computer word processing), c) near vision (NV), (ie. book reading). Primary objective of the study is the comparison in a series of ADLs of two cohorts of patients (group 1: subjects with bilateral bifocal lenses implantation, group 2: subjects with bilateral trifocal lenses implantation)

Study Overview

• Status: Unknown
• Conditions: Presbyopia
• Intervention / Treatment: Procedure: Phaco with Restor; Procedure: Phaco with Panoptix

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Greece
  • Evros
    • Alexandhroupolis, Evros, Greece, 68100
      • Recruiting
      • Democritus University of Thrace
      • Contact: Georgios Labiris, MD, PhD; Phone Number: 00302551030990; Email: labiris@usa.net

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

• Sampling Method: Non-Probability Sample

Study Population

Grade 1 Cataract Patients

Description

Inclusion Criteria:

• Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation

Exclusion Criteria:

• Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (BFG); (Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention).	Procedure: Phaco with Restor; Phacoemulsification with bilateral bifocal intraocular lenses implantation
Group 2 (TFG); (Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention).	Procedure: Phaco with Panoptix; Phacoemulsification with bilateral trifocal intraocular lenses implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Capacity (VC)	Assessment of Visual capacity (VC)	1 year following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant Visual Capacity (DVC)	Visual capacity for activities that require distant vision (DVC). DVC score will be measured by the performance score in the following ADLs: a) walking specific pathway, 2) walking up stairs, 3) walking down stairs, 4) day-time driving simulation, 5) night-time driving simulation	1 year following surgery
Intermediate Visual Capacity (IVC)	Visual Capacity for activities that require intermediate vision (IVC). VC score will be measured by the performance score in the following ADLs: a) reading ability of movie subtitles, b) reading ability of a predefined computer screen text, c) reading a supermarket badge	1 year following surgery
Near Visual Capacity (NVC)	Visual Capacity for activities that require near vision (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	1 year follwoing surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 299/13-1-2017

Plan for Individual participant data (IPD)

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