Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
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
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 20, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJuly 25, 2019
July 1, 2019
9 months
July 20, 2017
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
uNVC (3000K)
Uncorrected Near Vision Capacity at 3000 Kelvins
6 months
uNVC (4000K)
Uncorrected Near Vision Capacity at 4000 Kelvins
6 months
uNVC (6000K)
Uncorrected Near Vision Capacity at 6000 Kelvins
6 months
uNVC (25FC)
Uncorrected Near Vision Capacity at 25 Foot Candles
6 months
uNVC (50FC)
Uncorrected Near Vision Capacity at 50 Foot Candles
6 months
uNVC (75FC)
Uncorrected Near Vision Capacity at 75 Foot Candles
6 months
Study Arms (2)
Panoptix Group
ACTIVE COMPARATORPatients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix)
Control Group
NO INTERVENTIONControl, age-matched presbyopic group corrected with presbyopic glasses
Interventions
Phacoemulsification with bilateral diffractive trifocal lens implantation
Eligibility Criteria
You may qualify if:
- Presbyopia
You may not qualify if:
- Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Democritus University of Thrace
Alexandroupoli, Evros, 68100, Greece
Related Publications (1)
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.
PMID: 30587911DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Labiris, MD, PhD
Associate Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 20, 2017
First Posted
July 24, 2017
Study Start
July 1, 2017
Primary Completion
April 1, 2018
Study Completion
June 1, 2018
Last Updated
July 25, 2019
Record last verified: 2019-07