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

Sponsor

Democritus University of Thrace (Other)

Overall Status

Unknown status

CT.gov ID

NCT03021512

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Procedure: Phaco with Restor Procedure: Phaco with Panoptix

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Visual Capacity (VC) [1 year following surgery]
Assessment of Visual capacity (VC)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Democritus University of Thrace	Alexandhroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

Principal Investigator: Georgios Labiris, MD, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Assistant Professor, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT03021512

Other Study ID Numbers:

299/13-1-2017

First Posted:

Jan 16, 2017

Last Update Posted:

Jan 16, 2017

Last Verified:

Jan 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of Jan 16, 2017