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

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).

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: AT LISA TRI TORIC; Device: AT LISA TRI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04023062
    • IPEPO
  • São Paulo, Brazil, 04502-000
    • Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT LISA TRI TORIC; All patients will be undergo to phacoemulsification with IOL implantation bilateral	Device: AT LISA TRI TORIC; phacoemulsification with IOL implantation; Other Names: ZEISS AT LISA TRI TORIC
Experimental: AT LISA TRI; All patients will be undergo to phacoemulsification with IOL implantation bilateral	Device: AT LISA TRI; phacoemulsification with IOL implantation; Other Names: ZEISS AT LISA TRI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Instituto Paulista de Estudos e Pesquisa em Oftalmologia; Eye Clinic Day Hospital, São Paulo
• Investigators: Study Director: Rubens Belfort, MD, PhD, IPEPO Instituto Paulista de Estudos e Pesquisas em Oftalmologia

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): September 13, 2017

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: phacoemulsification; cataract; IOL; AT LISA TRI TORIC
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CAAE 49921915.1.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: paper publication