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

Federal University of São Paulo

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: AT LISA TRI

Device: AT LISA TRI TORIC

Study type

Interventional

Funder types

Other

Identifiers

NCT02770924

CAAE 49921915.1.0000.5505

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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