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

NCT ID: NCT03021512

Last Updated: 2017-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Presbyopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1 (BFG)

(Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention).

Phaco with Restor

Intervention Type PROCEDURE

Phacoemulsification with bilateral bifocal intraocular lenses implantation

Group 2 (TFG)

(Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention).

Phaco with Panoptix

Intervention Type PROCEDURE

Phacoemulsification with bilateral trifocal intraocular lenses implantation

Interventions

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Phaco with Restor

Phacoemulsification with bilateral bifocal intraocular lenses implantation

Intervention Type PROCEDURE

Phaco with Panoptix

Phacoemulsification with bilateral trifocal intraocular lenses implantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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Democritus University of Thrace

Alexandroupoli, Evros, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Dimitrios Aggelonias

Role: CONTACT

00302551039891

Facility Contacts

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Georgios Labiris, MD, PhD

Role: primary

00302551030990

Other Identifiers

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299/13-1-2017

Identifier Type: -

Identifier Source: org_study_id

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