Cataract SenileNCT04036149
To Compare Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
A study testing Intraocular lens in people with Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in Austria.
Trial summary
The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteAustria
- Study dates
- 14 Mar 2017to 20 Jul 2018
- 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;
- Assured follow-up examinations;
- Healthy eyes besides clinically significant bilateral age-related cataract.
- Distance corrected visual acuity ≤ 0.3 logMAR Normal findings in the medical history and physical examination
- Calculated IOL power within the available dioptre range;
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- Biometry measurement/cataract density compatible with the IOLMaster evaluation.
- Per operative inclusion criteria:
- IOL implanted in the capsular bag;
- The 2 IOL models (CT LUCIA 611P and CT ASPHINA 409MP) have been implanted in the 2 eyes of one patient;
- No intraoperative complications; no damaged capsular bag, no intraocular haemorrhage; no can opener rhexis.
Who cannot join
- 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 in either eye;
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.);
- Floppy iris syndrome;
- Diabetic retinopathy;
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- 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 last follow-up;
- Previous intraocular and corneal surgery;
- Expected postop. astigmatism greater than 1 D;
- Any type of corneal disorder;
- Dementia;
- Pseudoexfoliation syndrome (PEX);
- 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.
- Pregnancy and/or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
The main objective of the trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week post-operatively) as well as to the position stability of the reference IOL, CT ASPHINA 409MP.
- Conditions
- Cataract Senile
- Being tested
- Intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
Implantation as part of cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| LUCIA | Experimental | CT LUCIA 611P - Intraocular lens Receives: Device: Intraocular lens |
| ASPHINA | Active comparator | CT ASPHINA 409MP - Intraocular lens Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal position stability
Evaluation of the horizontal position stability of the CT LUCIA 611P IOL. The horizontal position at M1 and M4-6 will be compared to the horizontal IOL position at baseline (W1) and to the position stability of the reference IOL, CT ASPHINA 409MP.
Measured: 1 week to 4-6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start14 Mar 2017
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 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
- NCT04036149
- Sponsor's protocol ID
- CT LUCIA 611P BER-401-16
- Status last verified
- Jul 2019
- First submitted
- 26 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial to Compare the Postoperative Horizontal Position Stability of the CT LUCIA 611P and the CT ASPHINA 409MP
- ClinicalTrials.gov ID
- NCT04036149
- Acronym / sponsor ID
- CT LUCIA 611P BER-401-16
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 29 Jul 2019 (actual)
- 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 trial is to assess the efficacy of the CT LUCIA 611P intraocular lens (IOL) with regard to the horizontal IOL position stability. The horizontal position collected at 1 month and 4 to 6 months post-operatively will be compared to the horizontal IOL position recorded at baseline (1 week post-operatively) as well as to the position stability of the reference IOL, CT ASPHINA 409MP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUCIA | Experimental | Device: Intraocular lensCT LUCIA 611P - Intraocular lens |
| ASPHINA | Active comparator | Device: Intraocular lensCT ASPHINA 409MP - Intraocular lens |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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;
- Assured follow-up examinations;
- Healthy eyes besides clinically significant bilateral age-related cataract.
- Distance corrected visual acuity ≤ 0.3 logMAR Normal findings in the medical history and physical examination
Key exclusion criteria (20 listed)
- 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 in either eye;
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.);
- Floppy iris syndrome;
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 |
|---|---|---|
| Intraocular lensImplantation as part of cataract surgery | Device | ASPHINA, LUCIA |
Primary outcome
Horizontal position stability
Time frame: 1 week to 4-6 months post-operatively
Evaluation of the horizontal position stability of the CT LUCIA 611P IOL. The horizontal position at M1 and M4-6 will be compared to the horizontal IOL position at baseline (W1) and to the position stability of the reference IOL, CT ASPHINA 409MP.
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 31 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular lens in people with Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in Austria.
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 11 inclusion and 20 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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.
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?
Horizontal position stability (time frame: 1 week to 4-6 months post-operatively). 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 31 Jul 2019.