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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Presbyopia

Intervention / Treatment
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* Procedure: Phaco / Panoptix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presbyopia Exclusion Criteria: Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Panoptix Group<br>Patients will receive bilateral phacoemulsification with diffractive trifocal lenses implantation (Phaco / Panoptix) | Procedure: Phaco / Panoptix<br>* Phacoemulsification with bilateral diffractive trifocal lens implantation<br>|
| No Intervention: Control Group<br>Control, age-matched presbyopic group corrected with presbyopic glasses | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |