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Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL (NCT02770924)

Instituto Paulista de Estudos e Pesquisa em Oftalmologia
Eye Clinic Day Hospital, São Paulo
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).
  • Device: AT LISA TRI TORIC
    phacoemulsification with IOL implantation
    • ZEISS AT LISA TRI TORIC
  • Device: AT LISA TRI
    phacoemulsification with IOL implantation
    • ZEISS AT LISA TRI
Ages eligible for Study
50 Years and older
Genders eligible for Study
All
Accepts Healthy Volunteers
No
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
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.

2 locations

Brazil (2)
  • IPEPO
    Not specified
    São Paulo, Brazil, 04023062
  • Eye Clinic
    Not specified
    São Paulo, Brazil, 04502-000
Status:
completed
Type:
Interventional
Phase:
Start:
30 April, 2016
Updated:
12 September, 2017
Participants:
20
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