NCT03021512

Brief Summary

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)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 13, 2017

Last Update Submit

January 13, 2017

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Visual Capacity (VC)

    Assessment of Visual capacity (VC)

    1 year following surgery

Secondary Outcomes (3)

  • Distant Visual Capacity (DVC)

    1 year following surgery

  • Intermediate Visual Capacity (IVC)

    1 year following surgery

  • Near Visual Capacity (NVC)

    1 year follwoing surgery

Study Arms (2)

Group 1 (BFG)

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

Procedure: Phaco with Restor

Group 2 (TFG)

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

Procedure: Phaco with Panoptix

Interventions

Phaco with RestorPROCEDURE

Phacoemulsification with bilateral bifocal intraocular lenses implantation

Group 1 (BFG)
Phaco with PanoptixPROCEDURE

Phacoemulsification with bilateral trifocal intraocular lenses implantation

Group 2 (TFG)

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Grade 1 Cataract Patients

You may qualify if:

  • Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation

You may not qualify if:

  • Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

RECRUITING

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Georgios Labiris, MD, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Aggelonias

CONTACT

00302551039891dimagelonias@yahoo.com

Study Design

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

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)