Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation

NCT ID: NCT03226561

Last Updated: 2019-07-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-06-01

Brief Summary

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Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

Detailed Description

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Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Panoptix Group

Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)

Group Type ACTIVE_COMPARATOR

Phaco / Panoptix

Intervention Type PROCEDURE

Phacoemulsification with bilateral diffractive trifocal lens implantation

Control Group

Control, age-matched presbyopic group corrected with presbyopic glasses

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phaco / Panoptix

Phacoemulsification with bilateral diffractive trifocal lens implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Presbyopia

Exclusion Criteria

Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity
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

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Democritus University of Thrace

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

References

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Labiris G, Ntonti P, Panagiotopoulou EK, Konstantinidis A, Gkika M, Dardabounis D, Perente I, Sideroudi H. Impact of light conditions on reading ability following multifocal pseudophakic corrections. Clin Ophthalmol. 2018 Dec 14;12:2639-2646. doi: 10.2147/OPTH.S180766. eCollection 2018.

Reference Type DERIVED
PMID: 30587911 (View on PubMed)

Other Identifiers

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334/20-7-2017

Identifier Type: -

Identifier Source: org_study_id

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