NCT02770924

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	AT LISA TRI TORIC	phacoemulsification with IOL implantation
DEVICE	AT LISA TRI	phacoemulsification with IOL implantation

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-07-01
• Completion: 2017-09-13
• First posted: 2016-05-12
• Last updated: 2017-09-14

Locations

2 sites across 1 country: Brazil