Cataract SenileHECATE ANCT05201027
Study to Optimize the IOL Constant of a New Multifocal Intraocular Lens
A study testing trifocal intraocular lens in people with Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in El Salvador.
Trial summary
Prospective, non-comparative, multicenter study on medical device with 6 months follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Senile
- What is being tested?
- trifocal intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEl Salvador
- Study dates
- 28 Jan 2022to 27 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient of any gender;
- Patient with clinically significant bilateral age-related cataracts with planned phacoemulsification cataract extraction and suitable for implantation of a posterior chamber trifocal intraocular lens as determined by investigator's medical judgement;
- Projected postoperative corrected distance visual acuity (CDVA) better than 0.2 LogMAR as determined by investigator's medical judgement;
- Preoperative keratometric (corneal) astigmatism ≤1.5 D;
- Clear intraocular media other than cataract;
- Requiring an IOL power within the available range of the investigational IOL (15.0 to +27.0 D, in 0.5 D increments);
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- Patient agrees to have surgery of the second eye performed between 1 day and 10 days after the surgery of the first eye.
- Given written informed consent by patient;
- Patient willing and able to comply with examination procedures and schedule for follow-up visits;
Who cannot join
- Presence of uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.;
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), macular degeneration;
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or oedema as per Investigator's medical judgement; conditions including but not limited to keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia;
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium etc.);
- Use of and foreseeable use of systemic medications that may confound the outcome or increase the risk to the patient per investigator's medical judgement (e.g., steroids, Tamsulosin Hydrochloride or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g. small pupil/floppy iris syndrome], anti-metabolites, etc.);
- Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to cause future acuity loss to 0.2 LogMAR (CDVA) or worse;
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- Patients with conditions that increase the risk of zonular rupture during cataract extraction procedure that may affect the postoperative centration or tilt of the lens;
- Patients with previous refractive surgery procedures, including but not limited to LASIK, limbal relaxing incision;
- Planned concomitant ocular procedure during cataract surgery or within the next 6 months (e.g. glaucoma surgery including implantation of MIGS, astigmatic correction surgery, penetrating keratoplasty, laser-assisted in situ keratomileusis);
- Patients who are expected to require retinal laser treatment within the next 6 months per investigator's medical judgement;
- Amblyopia;
- Rubella, congenital, traumatic or complicated cataracts;
- History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis;
- Microphthalmos or macrophthalmos;
- Iris defects (e.g. aniridia);
- Optic nerve atrophy;
- Pseudoexfoliation;
- Keratoconus or irregular astigmatism;
- Inability to measure keratometry or biometry (including but not limited to cataract density, patient unable to focus for longer time etc.);
- Pathologic miosis;
- Pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes;
- Patient whose freedom is impaired by administrative or legal order;
- Concurrent participation in another drug or device investigation that could confound the outcome of this investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-comparative, Multicenter Trial to Optimize the IOL Constant of a New Multifocal IOL
Prospective, non-comparative, multicenter study on medical device with 6 months follow-up.
- Conditions
- Cataract Senile
- Being tested
- trifocal intraocular lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifocal intraocular lensDevice
cataract extraction and implantation of a posterior chamber trifocal intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| trifocal intraocular lens | Experimental | Implantation of new trifocal intraocular lens Receives: Device: trifocal intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of the IOL constant
Optimization of the calculated IOL constant with regression analysis by utilizing the following data measured during the study: Corneal radii, axial length, anterior chamber depth, IOL power, target refraction, manifest refraction and refraction distance
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 posted21 Jan 2022
- Study start28 Jan 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Why it stopped: Sponsor decided to modify the prototype device used in study
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 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
- NCT05201027
- Sponsor's protocol ID
- AT ELANA 841P-BER-301-19
- Acronym
- HECATE A
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2022
- Last updated
- 22 Aug 2022
- 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 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative, Multicenter Trial to Optimize the IOL Constant of a New Multifocal IOL
- ClinicalTrials.gov ID
- NCT05201027
- Acronym / sponsor ID
- HECATE A / AT ELANA 841P-BER-301-19
- Conditions
- Cataract Senile
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decided to modify the prototype device used in study
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 21 Jan 2022 (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.
Prospective, non-comparative, multicenter study on medical device with 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trifocal intraocular lens | Experimental | Device: trifocal intraocular lensImplantation of new trifocal intraocular lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient of any gender;
- Patient with clinically significant bilateral age-related cataracts with planned phacoemulsification cataract extraction and suitable for implantation of a posterior chamber trifocal intraocular lens as determined by investigator's medical judgement;
- Projected postoperative corrected distance visual acuity (CDVA) better than 0.2 LogMAR as determined by investigator's medical judgement;
- Preoperative keratometric (corneal) astigmatism ≤1.5 D;
- Clear intraocular media other than cataract;
Key exclusion criteria (23 listed)
- Presence of uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.;
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, glaucoma (uncontrolled despite intake of medication), macular degeneration;
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity, inflammation or oedema as per Investigator's medical judgement; conditions including but not limited to keratitis, keratoconjunctivitis, kerato uveitis, keratopathy, keratectasia;
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium etc.);
- Use of and foreseeable use of systemic medications that may confound the outcome or increase the risk to the patient per investigator's medical judgement (e.g., steroids, Tamsulosin Hydrochloride or other medications including anticholinergics or alpha-adrenergic blocking agents with similar side effects [e.g. small pupil/floppy iris syndrome], anti-metabolites, etc.);
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 |
|---|---|---|
| trifocal intraocular lenscataract extraction and implantation of a posterior chamber trifocal intraocular lens | Device | trifocal intraocular lens |
Primary outcome
Optimization of the IOL constant
Time frame: 6 months
Optimization of the calculated IOL constant with regression analysis by utilizing the following data measured during the study: Corneal radii, axial length, anterior chamber depth, IOL power, target refraction, manifest refraction and refraction distance
Results and safety
The study was stopped early (reason given: Sponsor decided to modify the prototype device used in study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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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 trifocal intraocular lens in people with Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in El Salvador.
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 9 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: stopped early, as of the sponsor's last update on 22 Aug 2022. 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 El Salvador. 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 was stopped early (reason given: Sponsor decided to modify the prototype device used in study). Results are not available in the source record.
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?
Optimization of the IOL constant (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 22 Aug 2022.