Senile CataractNCT06192901
Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses After Bilateral Cataract Surgery
An observational study of Senile Cataract, run by Carl Zeiss Meditec AG at 1 site in El Salvador.
Trial summary
Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Senile Cataract
- How many people
- 8 participants
- Where
- 1 siteEl Salvador
- Study dates
- 18 Sep 2023to 22 Sep 2023
- 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
- Adult, Older adult
Study population: Up to 20 eyes in 10 adult subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye and AT LISA tri 839MP in the second eye.
Who may be able to join
- Adult patient of any gender;
- Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
- Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
- The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
- Given written informed consent by patient.
Who cannot join
- Patients unable to meet the limitations of the protocol or likely of non-cooperation during the study
- 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 Limited Patient Cohort Follow-up Study to Assess the Long-term Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses in Bilateral Cataract Surgery
Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery
Read the detailed description
The main objective of this clinical investigation is to collect data on the IOLs AT ELANA 841P and AT LISA tri 839MP in subjects who underwent bilateral cataract surgery with the use of the two different types of IOLs to confirm the long-term performance and safety of the IOLs.
Retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery.
- Conditions
- Senile Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study eye AT ELANA 841P | Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye. | |
| Study eye AT LISA 839MP | Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT LISA tri 839MP in the second eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Corrected Distance Visual Acuity (CDVA)
Measured: 12 to 24 months after cataract surgery
Slit Lamp Examination
Measured: 12 to 24 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start18 Sep 2023
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 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
- NCT06192901
- Sponsor's protocol ID
- AT ELANA 841P-BER-401-23
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Limited Patient Cohort Follow-up Study to Assess the Long-term Safety and Performance of Hydrophobic and Hydrophilic Intraocular Lenses in Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT06192901
- Acronym / sponsor ID
- AT ELANA 841P-BER-401-23
- Conditions
- Senile Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 5 Jan 2024 (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.
Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery
Detailed description
The main objective of this clinical investigation is to collect data on the IOLs AT ELANA 841P and AT LISA tri 839MP in subjects who underwent bilateral cataract surgery with the use of the two different types of IOLs to confirm the long-term performance and safety of the IOLs.
Retro-prospective, comparative, non-interventional, non-randomized, single center study on medical devices with one follow-up visit after more than 12 months of a bilateral cataract surgery.Subjects who had a bilateral age-related cataract surgery with the IOLs AT ELANA 841P and AT LISA tri 839MP will be contacted and invited to attend a postoperative visit more than one year after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study eye AT ELANA 841P | – | –Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye. |
| Study eye AT LISA 839MP | – | –Subjects who underwent bilateral cataract surgery with the implantation of the IOL AT LISA tri 839MP in the second eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Up to 20 eyes in 10 adult subjects who underwent bilateral cataract surgery with the implantation of the IOL AT ELANA 841P in the first eye and AT LISA tri 839MP in the second eye.
Key inclusion criteria (5 listed)
- Adult patient of any gender;
- Patients who had an uncomplicated (no intra-operative complication) age-related cataract surgery
- Currently implanted with an IOL model AT ELANA 841P into the capsular bag in one eye and with the IOL model AT LISA tri 839MP into the capsular bag of the other eye.
- The postoperative visit was scheduled to be conducted more than one year after the second eye surgery.
- Given written informed consent by patient.
Key exclusion criteria (3 listed)
- Patients unable to meet the limitations of the protocol or likely of non-cooperation during the study
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Monocular Corrected Distance Visual Acuity (CDVA)
Time frame: 12 to 24 months after cataract surgery
Slit Lamp Examination
Time frame: 12 to 24 months after cataract 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 5 Jan 2024.
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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 Senile Cataract, 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 5 inclusion and 3 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 Jan 2024. 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 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?
Monocular Corrected Distance Visual Acuity (CDVA) (time frame: 12 to 24 months after cataract surgery). The study lists 2 primary outcomes in all. 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 Jan 2024.