CataractVICTORINCT02985723
Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
A study testing AT LISA tri toric 939MP in people with Cataract, run by Carl Zeiss Meditec AG.
Trial summary
The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs. 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 939MP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2016
- Phase
- Interventional
- 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
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- Man or woman, over 50 years of age
- Healthy eyes with bilateral cataract requiring surgical treatment for both eyes
- Bilateral regular corneal astigmatism (confirmed by topography measurement)
- Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial.
- Biometry measurement/cataract density compatible with the IOLMaster evaluation
- Bilateral uncomplicated cataract surgery and implantation into capsular bag by injector
- Assured follow-up examinations
Who cannot join
- Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial,
- Patients whose freedom is impaired by administrative or legal order,
- Monophtalmic patient.
- Previous ocular surgery, including corneal/refractive surgery,
- Chronic or recurrent uveitis,
- Acute ocular disease or external/internal infection,
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- Any kind of macular degeneration and impairment of retina (clinical diagnosis/OCT examination)
- Diabetes with retinal changes,
- Pseudoexfoliation syndrome
- Pathologic myosis
- Irregular astigmatism, especially keratoconus,
- Endothelial corneal dystrophy
- Glaucoma or IOP higher than 21mmHg under ocular hypertension treatment
- Aniridia
- Pseudophakia
- Cornea guttata; keratoplasty
- Amotio operation; anamnesis with vitreous surgery
- Amblyopia
- Intraocular tumours; endotamponade
- Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
- Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- Pupil diameter over 6 mm in mesopic condition
- Corneal opacity
About this study
Official title: Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
The aim of the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.
- Conditions
- Cataract
- Being tested
- AT LISA tri toric 939MP
- 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 toric 939MPDevice
| Study group | Role | What they receive |
|---|---|---|
| 939MP | Experimental | AT LISA tri toric 939MP intraocular lens Receives: Device: AT LISA tri toric 939MP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best distance-corrected visual acuity for intermediate vision after bilateral implantation
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMar 2013
- Primary completionJun 2016
- Study completionJun 2016
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piovella, Dr, Principal investigator, CMA - Centro Microchirurgia Ambulatoriale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985723
- Sponsor's protocol ID
- 2012-A01671-42
- Acronym
- VICTORI
- Status last verified
- Jan 2018
- First submitted
- 5 Dec 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Visual Outcome, Cylinder Correction and Patient Satisfaction After Implantation of AT LISA Tri Toric 939MP Intraocular Lenses
- ClinicalTrials.gov ID
- NCT02985723
- Acronym / sponsor ID
- VICTORI / 2012-A01671-42
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Dec 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 the present study is to evaluate the postoperative visual acuity for distance, intermediate and near vision as well as the cylinder correction and the patient satisfaction after bilateral implantation of AT LISA tri toric 939MP IOLs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 939MP | Experimental | Device: AT LISA tri toric 939MPAT LISA tri toric 939MP intraocular lens |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- Man or woman, over 50 years of age
- Healthy eyes with bilateral cataract requiring surgical treatment for both eyes
- Bilateral regular corneal astigmatism (confirmed by topography measurement)
- Only patients requiring intraocular lenses of a power comprised between sphere +0.0 and +28.0 dioptres and between a cylindrical range of +1.0 to +4.0D in both eyes will be able to participate in the trial.
Key exclusion criteria (23 listed)
- Patients unable to meet the limitations of the protocol or likely of non cooperation during the trial,
- Patients whose freedom is impaired by administrative or legal order,
- Monophtalmic patient.
- Previous ocular surgery, including corneal/refractive surgery,
- Chronic or recurrent uveitis,
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 toric 939MP | Device | 939MP |
Primary outcome
Best distance-corrected visual acuity for intermediate vision after bilateral implantation
Time frame: 12 months after surgery
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 29 Jan 2018.
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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.
Piovella, Dr principal investigator
CMA - Centro Microchirurgia Ambulatoriale
Questions about this trial
What is this clinical trial studying?
A study testing AT LISA tri toric 939MP in people with Cataract, run by Carl Zeiss Meditec AG.
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 8 inclusion and 23 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Best distance-corrected visual acuity for intermediate vision after bilateral implantation (time frame: 12 months after surgery). 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 29 Jan 2018.