CataractPhase 4NCT02770924
Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
A Phase 4 study testing AT LISA TRI TORIC and AT LISA TRI in people with Cataract, run by Federal University of São Paulo at 2 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AT LISA TRI TORIC and AT LISA TRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- May 2016to 13 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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).
Read the 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.
- Conditions
- Cataract
- Being tested
- AT LISA TRI TORIC, AT LISA TRI
- Keywords
- cataract, phacoemulsification, AT LISA TRI TORIC, IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT LISA TRI TORICDevice
Also called ZEISS AT LISA TRI TORIC
phacoemulsification with IOL implantation
AT LISA TRIDevice
Also called ZEISS AT LISA TRI
phacoemulsification with IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| AT LISA TRI TORIC | Experimental | All patients will be undergo to phacoemulsification with IOL implantation bilateral Receives: Device: AT LISA TRI TORIC |
| AT LISA TRI | Experimental | All patients will be undergo to phacoemulsification with IOL implantation bilateral Receives: Device: AT LISA TRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular visual acuity for far, intermediate and near distance
Visual acuity measurements
Measured: Changes from Pre-Op to Month 3
Secondary outcomes (3)
Defocus Curve
Test of Defocus Curve
Measured: Month 3
Contrast Sensitivity
Compare scores of contrast sensitivity pre-op and post-op
Measured: Changes from Pre-Op and Month 3
VFQ-25 Questionnaire
Compare answers between pre-op and post-op
Measured: Changes from Pre-Op and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Paulista de Estudos e Pesquisa em Oftalmologia, Eye Clinic Day Hospital, São Paulo
- Responsible party
- Principal investigator, Rubens Belfort Jr., Federal University of São Paulo
- Investigators
- Rubens Belfort, MD, PhD, Study director, IPEPO Instituto Paulista de Estudos e Pesquisas em Oftalmologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770924
- Sponsor's protocol ID
- CAAE 49921915.1.0000.5505
- Status last verified
- Aug 2017
- First submitted
- 4 May 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: paper publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Bilateral Implantation of ZEISS AT LISA TRI AND TRI TORIC IOL
- ClinicalTrials.gov ID
- NCT02770924
- Acronym / sponsor ID
- CAAE 49921915.1.0000.5505
- Conditions
- Cataract
- Keywords
- cataract, phacoemulsification, AT LISA TRI TORIC, IOL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Instituto Paulista de Estudos e Pesquisa em Oftalmologia, Eye Clinic Day Hospital, São Paulo
- Study start
- May 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT LISA TRI TORIC | Experimental | Device: AT LISA TRI TORICAll patients will be undergo to phacoemulsification with IOL implantation bilateral |
| AT LISA TRI | Experimental | Device: AT LISA TRIAll patients will be undergo to phacoemulsification with IOL implantation bilateral |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT LISA TRI TORICAlso: ZEISS AT LISA TRI TORICphacoemulsification with IOL implantation | Device | AT LISA TRI TORIC |
| AT LISA TRIAlso: ZEISS AT LISA TRIphacoemulsification with IOL implantation | Device | AT LISA TRI |
Primary outcome
Binocular visual acuity for far, intermediate and near distance
Time frame: Changes from Pre-Op to Month 3
Visual acuity measurements
3 secondary outcomes
Defocus Curve
Time frame: Month 3
Contrast Sensitivity
Time frame: Changes from Pre-Op and Month 3
VFQ-25 Questionnaire
Time frame: Changes from Pre-Op and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Individual participant dataSharing planned: Yes. paper publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens Belfort, MD, PhD study director
IPEPO Instituto Paulista de Estudos e Pesquisas em Oftalmologia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AT LISA TRI TORIC and AT LISA TRI in people with Cataract, run by Federal University of São Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular visual acuity for far, intermediate and near distance (time frame: Changes from Pre-Op to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.