CataractPost-opNCT06075459
Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
An observational study of Cataract, run by Hanita Lenses at 1 site in Argentina.
Trial summary
This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation. The study will also evaluate the patient satisfaction of the implanted patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Mar 2023to 5 Sep 2023
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.
Who may be able to join
- Implanted bilaterally using Hanita Intensity SL IOL
- 12 to 24 months post implantation
- Signed informed consent
Who cannot join
- Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation.
The study will also evaluate the patient satisfaction of the implanted patients.
Read the detailed description
Study Design:
This study is an ambispective, single arm single center, open label study.
Study Objectives:
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. The primary aim of this study is to evaluate the binocular defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.
The second aim of this study is to evaluate the patient satisfaction 12 to 24 months post-operation.
Study population:
Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.
Enrollment:
The study will encompass a total of 60 eligible subjects implanted bilaterally (120 eyes) in total who will complete the protocol follow-up schedule.
Duration of Subject participation:
Duration of Subject participation is at most one month Completion of active enrolment is anticipated to last approximately 6 months. The primary aim will be finally evaluated when the last study subject has been recruited.
Visits \& Procedures Patients participating in the trial will attend a total of one visit (1 year follow up visit).
Subjects will be selected from the physician's usual subjects' practice. All subjects meeting the inclusion criteria and having signed the Informed Consent Form will be evaluated by the Investigator according to the study protocol.
1 year follow up visit: Pre-operation Visit: performed to check inclusion criteria, and to sign the informed consent.
- Conditions
- Cataract
- Keywords
- Cataract, IOL, Hanita Lenses
- Medical subject headings
- 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 |
|---|---|---|
| Implanted patients with Intensity IOLs, 12-24 months previously | Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.
Performance of the IOL will be evaluated by assessing the defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.
Measured: 21-24 months post operation
Secondary outcomes (1)
The second aim of this study is to evaluate the patient satisfaction post-operation.
Patient satisfaction will be evaluated by using Quality of Life (VH14) and satisfaction Questionnaire
Measured: 21-24 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Mar 2023
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- German Bianchi, MD, Principal investigator, Dr. Nano Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075459
- Sponsor's protocol ID
- HTF-PM-AR
- Acronym
- Post-op
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
- ClinicalTrials.gov ID
- NCT06075459
- Acronym / sponsor ID
- Post-op / HTF-PM-AR
- Conditions
- Cataract
- Keywords
- Cataract, IOL, Hanita Lenses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 10 Oct 2023 (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.
This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation.
The study will also evaluate the patient satisfaction of the implanted patients.
Detailed description
Study Design:
This study is an ambispective, single arm single center, open label study.
Study Objectives:
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. The primary aim of this study is to evaluate the binocular defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.
The second aim of this study is to evaluate the patient satisfaction 12 to 24 months post-operation.
Study population:
Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.
Enrollment:
The study will encompass a total of 60 eligible subjects implanted bilaterally (120 eyes) in total who will complete the protocol follow-up schedule.
Duration of Subject participation:
Duration of Subject participation is at most one month Completion of active enrolment is anticipated to last approximately 6 months. The primary aim will be finally evaluated when the last study subject has been recruited.
Visits \& Procedures Patients participating in the trial will attend a total of one visit (1 year follow up visit).
Subjects will be selected from the physician's usual subjects' practice. All subjects meeting the inclusion criteria and having signed the Informed Consent Form will be evaluated by the Investigator according to the study protocol.
1 year follow up visit: Pre-operation Visit: performed to check inclusion criteria, and to sign the informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted patients with Intensity IOLs, 12-24 months previously | – | –Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.
Key inclusion criteria (3 listed)
- Implanted bilaterally using Hanita Intensity SL IOL
- 12 to 24 months post implantation
- Signed informed consent
Key exclusion criteria (1 listed)
- Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.
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
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.
Time frame: 21-24 months post operation
Performance of the IOL will be evaluated by assessing the defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.
1 secondary outcome
The second aim of this study is to evaluate the patient satisfaction post-operation.
Time frame: 21-24 months post operation
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 11 Oct 2023.
- Individual participant dataSharing planned: No
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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.
German Bianchi, MD principal investigator
Dr. Nano Eye Clinic
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, run by Hanita Lenses at 1 site in Argentina.
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 3 inclusion and 1 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 11 Oct 2023. 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 Argentina. 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?
The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. (time frame: 21-24 months post operation). 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 11 Oct 2023.