Assessment of Near Vision Capacity in Different Light Intensities

NCT ID: NCT03024073

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-30

Brief Summary

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Patients who underwent presbyopic correction with bilateral bifocal 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 oa patients who underwent presbyopic correction with bilateral bifocal intraocular 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

PROSPECTIVE

Study Groups

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SG

Study group (patients who underwent pseudophakic presbyopic correction with bilateral bifocal lenses implantation

BB-Phaco

Intervention Type PROCEDURE

Phacoemulsification with bilateral bifocal lenses implantation

CG

Control group (age-matched participants without pseudophakic presbyopic correction)

No interventions assigned to this group

Interventions

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BB-Phaco

Phacoemulsification with bilateral bifocal lenses 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

45 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

Democritus University of Thrace

Locations

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Democritus University of Thrace

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

Other Identifiers

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300/13-1/2017

Identifier Type: -

Identifier Source: org_study_id

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