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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
AT LISA TRI TORIC
AT LISA TRI
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, phacoemulsification, AT LISA TRI TORIC, IOL

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IPEPO
  • Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AT LISA TRI TORIC

AT LISA TRI

Arm Description

All patients will be undergo to phacoemulsification with IOL implantation bilateral

All patients will be undergo to phacoemulsification with IOL implantation bilateral

Outcomes

Primary Outcome Measures

Binocular visual acuity for far, intermediate and near distance
Visual acuity measurements

Secondary Outcome Measures

Defocus Curve
Test of Defocus Curve
Contrast Sensitivity
Compare scores of contrast sensitivity pre-op and post-op
VFQ-25 Questionnaire
Compare answers between pre-op and post-op

Full Information

First Posted
May 4, 2016
Last Updated
September 13, 2017
Sponsor
Federal University of São Paulo
Collaborators
Instituto Paulista de Estudos e Pesquisa em Oftalmologia, Eye Clinic Day Hospital, São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02770924
Brief Title
Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
Official Title
Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Instituto Paulista de Estudos e Pesquisa em Oftalmologia, Eye Clinic Day Hospital, São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, phacoemulsification, AT LISA TRI TORIC, IOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AT LISA TRI TORIC
Arm Type
Experimental
Arm Description
All patients will be undergo to phacoemulsification with IOL implantation bilateral
Arm Title
AT LISA TRI
Arm Type
Experimental
Arm Description
All patients will be undergo to phacoemulsification with IOL implantation bilateral
Intervention Type
Device
Intervention Name(s)
AT LISA TRI TORIC
Other Intervention Name(s)
ZEISS AT LISA TRI TORIC
Intervention Description
phacoemulsification with IOL implantation
Intervention Type
Device
Intervention Name(s)
AT LISA TRI
Other Intervention Name(s)
ZEISS AT LISA TRI
Intervention Description
phacoemulsification with IOL implantation
Primary Outcome Measure Information:
Title
Binocular visual acuity for far, intermediate and near distance
Description
Visual acuity measurements
Time Frame
Changes from Pre-Op to Month 3
Secondary Outcome Measure Information:
Title
Defocus Curve
Description
Test of Defocus Curve
Time Frame
Month 3
Title
Contrast Sensitivity
Description
Compare scores of contrast sensitivity pre-op and post-op
Time Frame
Changes from Pre-Op and Month 3
Title
VFQ-25 Questionnaire
Description
Compare answers between pre-op and post-op
Time Frame
Changes from Pre-Op and Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Belfort, MD, PhD
Organizational Affiliation
IPEPO Instituto Paulista de Estudos e Pesquisas em Oftalmologia
Official's Role
Study Director
Facility Information:
Facility Name
IPEPO
City
São Paulo
ZIP/Postal Code
04023062
Country
Brazil
Facility Name
Eye Clinic
City
São Paulo
ZIP/Postal Code
04502-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
paper publication

Learn more about this trial

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

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