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

Phase 4

Completed

• Conditions: Cataract

• Registration Number: NCT02770924
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Primary Completion: 2017-07
• Status Verified: 2017-08
• Study Completion: 2017-09-13
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Binocular visual acuity for far, intermediate and near distance	Changes from Pre-Op to Month 3	Visual acuity measurements

Secondary Outcome Measures

Name	Time	Method
Defocus Curve	Month 3	Test of Defocus Curve
Contrast Sensitivity	Changes from Pre-Op and Month 3	Compare scores of contrast sensitivity pre-op and post-op
VFQ-25 Questionnaire	Changes from Pre-Op and Month 3	Compare answers between pre-op and post-op

Trial Locations

Locations (2)

IPEPO; 🇧🇷 São Paulo, Brazil

Eye Clinic; 🇧🇷 São Paulo, Brazil