NCT03024073

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

January 14, 2017

Last Update Submit

July 24, 2019

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Near Vision Acuity (UnVA)

    Near Vision Acuity

    6 months

Secondary Outcomes (1)

  • Near Vision Capacity (NVC)

    6 months

Study Arms (2)

SG

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

Procedure: BB-Phaco

CG

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

Interventions

BB-PhacoPROCEDURE

Phacoemulsification with bilateral bifocal lenses implantation

SG

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral bifocal intraocular lenses implantation

You may qualify if:

  • Presbyopia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Georgios Labiris, MD, PhD

    Democritus University of Thrace

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 18, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)