CatartactLUCIOLNCT02903927
Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
A study testing Implantation of CT LUCIA IOL and Implantation of Acrysof IQ SN60WF IOL in people with Catartact, run by Carl Zeiss Meditec AG.
Trial summary
The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Catartact
- What is being tested?
- Implantation of CT LUCIA IOL and Implantation of Acrysof IQ SN60WF IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2014to 10 Oct 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 to 90 years
- 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;
- Patients of any gender, aged 50 to 90 years;
- Senile cataract in at least 1 eye;
- Assured follow-up examinations;
- Healthy eyes besides clinically significant cataract
- Biometry measurement/cataract density compatible with the IOLMaster evaluation.
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- Post-operative inclusion criteria:
- IOL implanted in the capsular bag;
- The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;
- No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.
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;
- Current participation in another drug or device investigation;
- Allergy to heparin
- Monophthalmic patient
- Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse the operated eye
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- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
- Diabetic retinopathy
- Traumatic cataract
- Aniridia
- Microphthalmus
- Amblyopia
- Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- Patient expected to require retinal laser treatment before the end of the follow-up
- Previous intraocular and corneal surgery
- Expected postop. astigmatism greater than 1 D
- Any type of corneal disorder
- Dementia
- Diabetes mellitus
- Pseudoexfoliation syndrome (PXF)
- Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
About this study
Official title: Prospective Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.
- Conditions
- Catartact
- Being tested
- Implantation of CT LUCIA IOL, Implantation of Acrysof IQ SN60WF IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of CT LUCIA IOLDevice
Implantation of Acrysof IQ SN60WF IOLDevice
| Study group | Role | What they receive |
|---|---|---|
| CT LUCIA | Experimental | Not described Receives: Device: Implantation of CT LUCIA IOL |
| Acrysof IQ Sn60WF | Active comparator | Not described Receives: Device: Implantation of Acrysof IQ SN60WF IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance visual acuity (UCVA) (monocular)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start20 May 2014
- Primary completion6 Jun 2016
- Study completion10 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatartactStudies 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903927
- Sponsor's protocol ID
- CT LUCIA 601PY BER 401-14
- Acronym
- LUCIOL
- Status last verified
- Jan 2018
- First submitted
- 9 Sep 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT02903927
- Acronym / sponsor ID
- LUCIOL / CT LUCIA 601PY BER 401-14
- Conditions
- Catartact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 20 May 2014 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 10 Oct 2016 (actual)
- First posted
- 16 Sep 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 main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT LUCIA | Experimental | Device: Implantation of CT LUCIA IOL |
| Acrysof IQ Sn60WF | Active comparator | Device: Implantation of Acrysof IQ SN60WF IOL |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
- Patients of any gender, aged 50 to 90 years;
- Senile cataract in at least 1 eye;
- Assured follow-up examinations;
- Healthy eyes besides clinically significant cataract
Key exclusion criteria (22 listed)
- • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial;
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 |
|---|---|---|
| Implantation of CT LUCIA IOL | Device | CT LUCIA |
| Implantation of Acrysof IQ SN60WF IOL | Device | Acrysof IQ Sn60WF |
Primary outcome
Uncorrected distance visual acuity (UCVA) (monocular)
Time frame: 6 months
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.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of CT LUCIA IOL and Implantation of Acrysof IQ SN60WF IOL in people with Catartact, 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 10 inclusion and 22 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?
Uncorrected distance visual acuity (UCVA) (monocular) (time frame: 6 months). 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.