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

Study Overview
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Brief Summary
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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)

Official Title
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Retrospective Functional Assessment of Activities of Daily Living (ADL) in Patients Who Underwent Bilateral Implantation of Aspheric Bifocal Intraocular Lenses or Aspheric Trifocal Intraocular Lenses

Conditions
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Presbyopia

Intervention / Treatment
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* Procedure: Phaco with Restor
* Procedure: Phaco with Panoptix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presbyopic patients that underwent either bilateral bifocal or trifocal intraocular lenses implantation Exclusion Criteria: Glaucoma, Corneal pathology, Fundus pathology, Mental or Neurological disorder

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (BFG)<br>(Bifocal group). Subjects that underwent bifocal intraocular lenses implantation. (ie. Phaco with Restor intervention). | Procedure: Phaco with Restor<br>* Phacoemulsification with bilateral bifocal intraocular lenses implantation<br>|
| Group 2 (TFG)<br>(Trifocal group). Subjects that underwent trifocal intraocular lenses implantation. (ie. Phaco with Panoptix intervention). | Procedure: Phaco with Panoptix<br>* Phacoemulsification with bilateral trifocal intraocular lenses implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Capacity (VC) | Assessment of Visual capacity (VC) | 1 year following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year following surgery | 
| 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 | 1 year following surgery | 
| 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 | 1 year follwoing surgery |