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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03021512
• Other study ID #: 299/13-1-2017
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2017
• Last updated: January 13, 2017
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: Democritus University of Thrace
• Contact: Dimitrios Aggelonias
• Phone: 00302551039891
• Email: dimagelonias[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

Procedure:
• Phaco with Restor
Phacoemulsification with bilateral bifocal intraocular lenses implantation
• Phaco with Panoptix
Phacoemulsification with bilateral trifocal intraocular lenses implantation

Locations

Country	Name	City	State
Greece	Democritus University of Thrace	Alexandhroupolis	Evros

Sponsors (1)

Lead Sponsor	Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Capacity (VC)	Assessment of Visual capacity (VC)	1 year following surgery
Secondary	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
Secondary	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
Secondary	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