Cataract SenileNCT04998409
Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens
An observational study of Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens 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?
- Monofocal lens
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2021to 22 Apr 2022
- Phase
- Observational
- 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
Study population: Patients implanted with the study lens
Who may be able to join
- Patients of any gender, aged 18 years or older at the time of the surgery
- Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
- Currently implanted with the study IOL into the capsular bag in at least one eye
- One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
- Patient is willing and capable of providing informed consent
- Patient is willing and capable of complying with visits and procedures as defined by this protocol
Who cannot join
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
- Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
- Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
- Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
Show all 16Show fewer
- Any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
- Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
- Any previous preoperative intraocular and corneal surgery
- Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
- Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
- Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
- Women during pregnancy and/or lactation at time of enrollment into the study
- 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
- Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens
Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens
Read the detailed description
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.
- Conditions
- Cataract Senile
- Being tested
- Monofocal lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofocal lensDevice
not applicable as patients are already implanted with the monofocal lens
| Study group | Role | What they receive |
|---|---|---|
| Monofocal IOL | Not described Receives: Device: Monofocal lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Monocular visual acuity at far distance (4m) using sloan letters
Measured: 12 to 24 months after the implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start24 Sep 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 242 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
- NCT04998409
- Sponsor's protocol ID
- SPHERIS 209 BER-401-20
- Status last verified
- May 2022
- First submitted
- 2 Aug 2021
- Last updated
- 5 May 2022
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens
- ClinicalTrials.gov ID
- NCT04998409
- Acronym / sponsor ID
- SPHERIS 209 BER-401-20
- Conditions
- Cataract Senile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 10 Aug 2021 (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.
Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens
Detailed description
To show safety and the effectiveness in regard to the monocular corrected distance visual acuity (CDVA) at 12-24 month postoperative.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monofocal IOL | – | Device: Monofocal lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with the study lens
Key inclusion criteria (6 listed)
- Patients of any gender, aged 18 years or older at the time of the surgery
- Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
- Currently implanted with the study IOL into the capsular bag in at least one eye
- One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
- Patient is willing and capable of providing informed consent
Key exclusion criteria (16 listed)
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
- Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
- Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
- Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
- Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
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 |
|---|---|---|
| Monofocal lensnot applicable as patients are already implanted with the monofocal lens | Device | Monofocal IOL |
Primary outcome
Visual acuity
Time frame: 12 to 24 months after the implantation
Monocular visual acuity at far distance (4m) using sloan letters
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 5 May 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?
An observational study of Cataract Senile, run by Carl Zeiss Meditec AG at 1 site in Germany.
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 6 inclusion and 16 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 5 May 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 Germany. 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?
Visual acuity (time frame: 12 to 24 months after the implantation). 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 5 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.