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

• Conditions: Presbyopia

• Registration Number: NCT03021512
• Lead Sponsor: Democritus University of Thrace

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-16
• Last Update Posted: 2017-01-16
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Capacity (VC)	1 year following surgery	Assessment of Visual capacity (VC)

Secondary Outcome Measures

Name	Time	Method
Distant Visual Capacity (DVC)	1 year following surgery	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
Intermediate Visual Capacity (IVC)	1 year following surgery	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
Near Visual Capacity (NVC)	1 year follwoing surgery	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

Trial Locations

Locations (1)

Democritus University of Thrace; 🇬🇷 Alexandhroupolis, Evros, Greece

Democritus University of Thrace

🇬🇷Alexandhroupolis, Evros, Greece

Georgios Labiris, MD, PhD

Contact

00302551030990

labiris@usa.net