NCT04263636

Brief Summary

Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

February 7, 2020

Last Update Submit

March 27, 2021

Conditions

Keywords

pseudophakic presbyopic correctiontrifocal intraocular lenslight intensityeye light transmittancelight efficiency function

Outcome Measures

Primary Outcomes (1)

  • Minimum light intensity

    Minimum light intensity in which participants reach their maximum critical visual acuity

    6 months postoperatively

Secondary Outcomes (1)

  • Critical Visual Acuity (CVA)

    6 months postoperatively

Study Arms (2)

Study group

Patients that underwent uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs (PanOptix or PanOptix toric, Alcon Laboratories, Inc., Fort Worth, TX, USA)

Procedure: Phacoemulsification with bilateral trifocal diffractive IOLs

Control group

Patients of similar age without cataract that their crystalline lens has not been replaced.

Interventions

Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs

Study group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • age between 45 to 70 years

You may not qualify if:

  • astigmatism \>1.00 diopters
  • glaucoma
  • former incisional eye surgery
  • corneal or fundus disease
  • diabetes mellitus
  • autoimmune diseases
  • neurological or psychiatric diseases
  • posterior capsule rupture or lens misalignment
  • postoperative uncorrected bilateral distant visual acuity \< 8/10.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

  • Labiris G, Panagiotopoulou EK, Taliantzis S, Perente A, Delibasis K, Doulos LT. Lighting Standards Revisited: Introduction of a Mathematical Model for the Assessment of the Impact of Illuminance on Visual Acuity. Clin Ophthalmol. 2021 Nov 28;15:4553-4564. doi: 10.2147/OPTH.S326139. eCollection 2021.

MeSH Terms

Conditions

Presbyopia

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Georgios Labiris, MD, PhD

    Associate Professor

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Ophthalmology

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

January 7, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations