Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL

Study Overview
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Brief Summary
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The aim of this study is to evaluate the visual function of patients with bilateral implantation of the IOL trifocal ZEISS AT LISA TRI AND TRI TORIC by means of visual acuity tests with and without optical correction, sensitivity curve contrast, defocus curve and quality questionnaire visual function (VFQ-25).

Detailed Description
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Twenty patients (40 eyes) diagnosed with cataracts and cataract surgery indication will be selected to participate in this study. The surgery will be performed by the same surgeon with 2 week interval between surgery the first and second eye. After approval of the research project by the Research Ethics Committee all patients should understand and sign the Informed Consent and Informed (IC) before surgery. All patients will be operated by conventional phacoemulsification with implantation of intraocular lens provided by the manufacturer. Patients will have five study visits, including the preoperative visit, operative visit four postoperative visits. All patients will be submitted to the following routine assessments preoperatively and demographic patient information will be recorded and a detailed medical history will be obtained. VFQ-25 Questionnaire Identification of the dominant eye; Visual acuity Refraction Slit lamp examination Tonometry Self-keratometry; Corneal topography; Microscopy speculate Fundus examination. In addition, all routine preoperative measures will be performed. lens power calculations should be performed on both eyes to ensure qualification (lens power within the diopter range (D) available) and prepare for surgery (getting the lens). The emmetropia (± 0.5 D) should be the target of patients.

Official Title
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Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: AT LISA TRI TORIC
* Device: AT LISA TRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 50 years Cataract diagnosis indicating surgery in both eyes Corneal astigmatism to 12D (AT lisa tri toric) Corneal astigmatism less than 0,75D (AT lisa tri) Ability to provide consent and clarification for study participation Exclusion Criteria: Significant irregular corneal astigmatism as shown by Corneal topography; Corneal astigmatism up 12D Patients diagnosed with severe visual degenerative disorders (e.g. macular degeneration or other disorder of the retina) Previous corneal surgery; Amblyopia Planning for multiple procedures, including IRL, LASIK, etc. during surgery or during the study Endothelial dystrophy clinically significant cornea (eg, Fuchs dystrophy) Corneal disease activity (eg, herpes simplex, herpes zoster, etc.) Severe diabetic retinopathy Retinal detachment Glaucoma Patients presenting illness or acute conditions or chronic severe that in the opinion of the investigator, would increase the surgical risk or confound the research results Any patient who is taking part in another study involving ocular surgery

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT LISA TRI TORIC<br>All patients will be undergo to phacoemulsification with IOL implantation bilateral | Device: AT LISA TRI TORIC<br>* phacoemulsification with IOL implantation<br>* Other names: ZEISS AT LISA TRI TORIC;|
| Experimental: AT LISA TRI<br>All patients will be undergo to phacoemulsification with IOL implantation bilateral | Device: AT LISA TRI<br>* phacoemulsification with IOL implantation<br>* Other names: ZEISS AT LISA TRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular visual acuity for far, intermediate and near distance | Visual acuity measurements | Changes from Pre-Op to Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defocus Curve | Test of Defocus Curve | Month 3 | 
| Contrast Sensitivity | Compare scores of contrast sensitivity pre-op and post-op | Changes from Pre-Op and Month 3 | 
| VFQ-25 Questionnaire | Compare answers between pre-op and post-op | Changes from Pre-Op and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, phacoemulsification, AT LISA TRI TORIC, IOL