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

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ClinicalTrials.gov Identifier: NCT02770924
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
Instituto Paulista de Estudos e Pesquisa em Oftalmologia
Eye Clinic Day Hospital, São Paulo
Information provided by (Responsible Party):
Rubens Belfort Jr., 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).

Condition or disease Intervention/treatment Phase
Cataract Device: AT LISA TRI TORIC Device: AT LISA TRI Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
Study Start Date : May 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : September 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: AT LISA TRI TORIC
All patients will be undergo to phacoemulsification with IOL implantation bilateral
Device: AT LISA TRI TORIC
phacoemulsification with IOL implantation
Other Name: ZEISS AT LISA TRI TORIC

Experimental: AT LISA TRI
All patients will be undergo to phacoemulsification with IOL implantation bilateral
Device: AT LISA TRI
phacoemulsification with IOL implantation
Other Name: ZEISS AT LISA TRI




Primary Outcome Measures :
  1. Binocular visual acuity for far, intermediate and near distance [ Time Frame: Changes from Pre-Op to Month 3 ]
    Visual acuity measurements


Secondary Outcome Measures :
  1. Defocus Curve [ Time Frame: Month 3 ]
    Test of Defocus Curve

  2. Contrast Sensitivity [ Time Frame: Changes from Pre-Op and Month 3 ]
    Compare scores of contrast sensitivity pre-op and post-op

  3. VFQ-25 Questionnaire [ Time Frame: Changes from Pre-Op and Month 3 ]
    Compare answers between pre-op and post-op



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770924


Locations
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Brazil
IPEPO
São Paulo, Brazil, 04023062
Eye Clinic
São Paulo, Brazil, 04502-000
Sponsors and Collaborators
Federal University of São Paulo
Instituto Paulista de Estudos e Pesquisa em Oftalmologia
Eye Clinic Day Hospital, São Paulo
Investigators
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Study Director: Rubens Belfort, MD, PhD IPEPO Instituto Paulista de Estudos e Pesquisas em Oftalmologia

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Responsible Party: Rubens Belfort Jr., Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02770924     History of Changes
Other Study ID Numbers: CAAE 49921915.1.0000.5505
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: paper publication
Keywords provided by Rubens Belfort Jr., Federal University of São Paulo:
cataract
phacoemulsification
AT LISA TRI TORIC
IOL
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases