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Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation

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ClinicalTrials.gov Identifier: NCT03226561
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace

Brief Summary:
Patients who underwent presbyopic correction with bilateral trifocal 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 of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

Condition or disease Intervention/treatment Phase
Presbyopia Procedure: Phaco / Panoptix Not Applicable

Detailed Description:
Patients who underwent presbyopic correction with bilateral trifocal 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 of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Panoptix Group
Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)
Procedure: Phaco / Panoptix
Phacoemulsification with bilateral diffractive trifocal lens implantation

No Intervention: Control Group
Control, age-matched presbyopic group corrected with presbyopic glasses



Primary Outcome Measures :
  1. uNVC (3000K) [ Time Frame: 6 months ]
    Uncorrected Near Vision Capacity at 3000 Kelvins

  2. uNVC (4000K) [ Time Frame: 6 months ]
    Uncorrected Near Vision Capacity at 4000 Kelvins

  3. uNVC (6000K) [ Time Frame: 6 months ]
    Uncorrected Near Vision Capacity at 6000 Kelvins

  4. uNVC (25FC) [ Time Frame: 6 months ]
    Uncorrected Near Vision Capacity at 25 Foot Candles

  5. uNVC (50FC) [ Time Frame: 6 months ]
    Uncorrected Near Vision Capacity at 50 Foot Candles

  6. uNVC (75FC) [ Time Frame: 6 months ]
    Uncorrected Near Vision Capacity at 75 Foot Candles



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Presbyopia

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226561


Locations
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Greece
Democritus University of Thrace
Alexandroúpoli, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
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Principal Investigator: Georgios Labiris, MD, PhD Associate Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Georgios Labiris, Associate Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT03226561     History of Changes
Other Study ID Numbers: 334/20-7-2017
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases