Assessment of Near Vision Capacity in Different Light Intensities

Sponsor

Democritus University of Thrace (Other)

Overall Status

Completed

CT.gov ID

NCT03024073

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Procedure: BB-Phaco

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Near Vision Capacity in Different Light Intensities and Temperatures in Patients Who Underwent Pseudophakic Presbyopic Correction

Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
SG Study group (patients who underwent pseudophakic presbyopic correction with bilateral bifocal lenses implantation	Procedure: BB-Phaco Phacoemulsification with bilateral bifocal lenses implantation
CG Control group (age-matched participants without pseudophakic presbyopic correction)

Arm

Intervention/Treatment

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

Procedure: BB-Phaco

Phacoemulsification with bilateral bifocal lenses implantation

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

Outcome Measures

Primary Outcome Measures

Uncorrected Near Vision Acuity (UnVA) [6 months]
Near Vision Acuity

Secondary Outcome Measures

Near Vision Capacity (NVC) [6 months]
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:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Presbyopia

Exclusion Criteria:

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

Democritus University of Thrace

Investigators

Principal Investigator: Georgios Labiris, MD, PhD, Democritus University of Thrace

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Assistant Professor, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT03024073

Other Study ID Numbers:

300/13-1/2017

First Posted:

Jan 18, 2017

Last Update Posted:

Jul 25, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Presbyopia

Study Results

No Results Posted as of Jul 25, 2019