Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
1 other identifier
interventional
20
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2017
CompletedSeptember 14, 2017
August 1, 2017
1.2 years
May 4, 2016
September 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Binocular visual acuity for far, intermediate and near distance
Visual acuity measurements
Changes from Pre-Op to Month 3
Secondary Outcomes (3)
Defocus Curve
Month 3
Contrast Sensitivity
Changes from Pre-Op and Month 3
VFQ-25 Questionnaire
Changes from Pre-Op and Month 3
Study Arms (2)
AT LISA TRI TORIC
EXPERIMENTALAll patients will be undergo to phacoemulsification with IOL implantation bilateral
AT LISA TRI
EXPERIMENTALAll patients will be undergo to phacoemulsification with IOL implantation bilateral
Interventions
phacoemulsification with IOL implantation
phacoemulsification with IOL implantation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IPEPO
São Paulo, 04023062, Brazil
Eye Clinic
São Paulo, 04502-000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rubens Belfort, MD, PhD
IPEPO Instituto Paulista de Estudos e Pesquisas em Oftalmologia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 12, 2016
Study Start
May 1, 2016
Primary Completion
July 1, 2017
Study Completion
September 13, 2017
Last Updated
September 14, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share
paper publication