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Status unknownNCT03021512Updated Jan 16, 2017

Functional Assessment of ADL in Patients Who Underwent Bifocal and Trifocal Presbyopic Correction

An observational study in Presbyopia, sponsored by Democritus University of Thrace. Status unknown at 1 site in Greece. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-16.

Sponsored by Democritus University of Thrace · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
50 Years to 65 Years
Sex
All
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Study 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)

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Conditions studied

  • Presbyopia

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In context

Presbyopia

324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 51 observational studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Grade 1 Cataract Patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedurePhaco with Restor

    Phacoemulsification with bilateral bifocal intraocular lenses implantation

  • ProcedurePhaco with Panoptix

    Phacoemulsification with bilateral trifocal intraocular lenses implantation

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What researchers measure

Primary outcomes

  1. Visual Capacity (VC)

    Assessment of Visual capacity (VC)

    Time frame: 1 year following surgery

Secondary outcomes

  1. Distant Visual Capacity (DVC)

    Visual capacity for activities that require distant vision (DVC). DVC score will be measured by the performance score in the following ADLs: a) walking specific pathway, 2) walking up stairs, 3) walking down stairs, 4) day-time driving simulation, 5) night-time driving simulation

    Time frame: 1 year following surgery

  2. Intermediate Visual Capacity (IVC)

    Visual Capacity for activities that require intermediate vision (IVC). VC score will be measured by the performance score in the following ADLs: a) reading ability of movie subtitles, b) reading ability of a predefined computer screen text, c) reading a supermarket badge

    Time frame: 1 year following surgery

  3. Near Visual Capacity (NVC)

    Visual Capacity for activities that require near vision (NVC). 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

    Time frame: 1 year follwoing surgery

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Study locations

1 of 1 sites recruiting
  • Democritus University of Thrace
    Alexandhroupolis, Evros 68100, Greece
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03021512
Lead sponsor
Democritus University of Thrace
Responsible party
Georgios Labiris (Assistant Professor, Democritus University of Thrace) — Principal investigator
First posted
Jan 16, 2017
Start date
Jan 2017
Primary completion
Jan 2018 (estimated)
Completion
Jan 2018 (estimated)
Last update
Jan 16, 2017

Study contacts

Dimitrios Aggelonias
Contact
dimagelonias@yahoo.com
00302551039891
Georgios Labiris, MD, PhD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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