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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770924
• Other study ID #: CAAE 49921915.1.0000.5505
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2016
• Last updated: September 13, 2017
• Start date: May 2016
• Est. completion date: September 13, 2017

Study information

• Verified date: August 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 13, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AT LISA TRI TORIC
phacoemulsification with IOL implantation
• AT LISA TRI
phacoemulsification with IOL implantation

Locations

Country	Name	City	State
Brazil	Eye Clinic	São Paulo
Brazil	IPEPO	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Eye Clinic Day Hospital, São Paulo, Instituto Paulista de Estudos e Pesquisa em Oftalmologia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular visual acuity for far, intermediate and near distance	Visual acuity measurements	Changes from Pre-Op to Month 3
Secondary	Defocus Curve	Test of Defocus Curve	Month 3
Secondary	Contrast Sensitivity	Compare scores of contrast sensitivity pre-op and post-op	Changes from Pre-Op and Month 3
Secondary	VFQ-25 Questionnaire	Compare answers between pre-op and post-op	Changes from Pre-Op and Month 3