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OpenTrials
Completed

NCT Number: NCT02770924

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

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye Clinic, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT LISA TRI TORIC

Device

phacoemulsification with IOL implantation

Other names: ZEISS AT LISA TRI TORIC

AT LISA TRI

Device

phacoemulsification with IOL implantation

Other names: ZEISS AT LISA TRI

Primary outcomes

  1. Binocular visual acuity for far, intermediate and near distance

    Time frame: Changes from Pre-Op to Month 3

    Visual acuity measurements

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Eye Clinic Day Hospital, São Paulo
  • Instituto Paulista de Estudos e Pesquisa em Oftalmologia

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 12, 2016
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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