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

Primary Purpose

Presbyopia

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Phaco / Panoptix
Sponsored by
Democritus University of Thrace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Presbyopia

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Presbyopia

Exclusion Criteria:

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

Sites / Locations

  • Democritus University of Thrace

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Panoptix Group

Control Group

Arm Description

Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)

Control, age-matched presbyopic group corrected with presbyopic glasses

Outcomes

Primary Outcome Measures

uNVC (3000K)
Uncorrected Near Vision Capacity at 3000 Kelvins
uNVC (4000K)
Uncorrected Near Vision Capacity at 4000 Kelvins
uNVC (6000K)
Uncorrected Near Vision Capacity at 6000 Kelvins
uNVC (25FC)
Uncorrected Near Vision Capacity at 25 Foot Candles
uNVC (50FC)
Uncorrected Near Vision Capacity at 50 Foot Candles
uNVC (75FC)
Uncorrected Near Vision Capacity at 75 Foot Candles

Secondary Outcome Measures

Full Information

First Posted
July 20, 2017
Last Updated
July 24, 2019
Sponsor
Democritus University of Thrace
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1. Study Identification

Unique Protocol Identification Number
NCT03226561
Brief Title
Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Official Title
Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Democritus University of Thrace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panoptix Group
Arm Type
Active Comparator
Arm Description
Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control, age-matched presbyopic group corrected with presbyopic glasses
Intervention Type
Procedure
Intervention Name(s)
Phaco / Panoptix
Intervention Description
Phacoemulsification with bilateral diffractive trifocal lens implantation
Primary Outcome Measure Information:
Title
uNVC (3000K)
Description
Uncorrected Near Vision Capacity at 3000 Kelvins
Time Frame
6 months
Title
uNVC (4000K)
Description
Uncorrected Near Vision Capacity at 4000 Kelvins
Time Frame
6 months
Title
uNVC (6000K)
Description
Uncorrected Near Vision Capacity at 6000 Kelvins
Time Frame
6 months
Title
uNVC (25FC)
Description
Uncorrected Near Vision Capacity at 25 Foot Candles
Time Frame
6 months
Title
uNVC (50FC)
Description
Uncorrected Near Vision Capacity at 50 Foot Candles
Time Frame
6 months
Title
uNVC (75FC)
Description
Uncorrected Near Vision Capacity at 75 Foot Candles
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presbyopia Exclusion Criteria: Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Labiris, MD, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Democritus University of Thrace
City
Alexandroúpoli
State/Province
Evros
ZIP/Postal Code
68100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30587911
Citation
Labiris G, Ntonti P, Panagiotopoulou EK, Konstantinidis A, Gkika M, Dardabounis D, Perente I, Sideroudi H. Impact of light conditions on reading ability following multifocal pseudophakic corrections. Clin Ophthalmol. 2018 Dec 14;12:2639-2646. doi: 10.2147/OPTH.S180766. eCollection 2018.
Results Reference
derived

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

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