CataractcataractsNCT03455114
A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
A study testing AssiAnchor in people with Cataract, run by Hanita Lenses at 1 site in Israel.
Trial summary
The AssiAnchor 2 is a fixation ophthalmic device. The device is manufactured by Hanita Lenses from PMMA material which is being used for the production of Intra-ocular lenses. The device is intended for patients requiring capsule centration to clip the anterior lens capsule between the arms of the device and secure it… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- AssiAnchor
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Mar 2018to 9 Jun 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requires capsule centration during or after cataract surgery.
- Understands the study requirements and the treatment procedures
- Sign Informed Consent before any study-specific tests or procedures.
Who cannot join
- Diagnosed with active anterior segment intraocular inflammation.
- Obligated to participation in another clinical study within the past 30 days.
- Pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The AssiAnchor 2 is a fixation ophthalmic device. The device is manufactured by Hanita Lenses from PMMA material which is being used for the production of Intra-ocular lenses.
The device is intended for patients requiring capsule centration to clip the anterior lens capsule between the arms of the device and secure it to the scleral wall.
Read the detailed description
Intended Use:
The AssiAnchor is a device which is intended to be implanted permanently in the posterior chamber of the eye for fixation of subluxated capsule.
Study Objectives:
The primary aim of this study is to assess the safety and performance of the new AssiAnchor. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period.
Study population:
Men and women diagnosed with subluxated capsular bag that require lens removal surgery or in malpositioned pseudophakia that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 10 subjects will be enrolled.
Investigational sites:
One (1) center will participate in this study.
Duration of Subject participation:
Completion of active enrolment is anticipated to last approximately 12 months. The objectives of this study will be achieved when the final study subject has completed 3 months follow-up.
Primary Safety Endpoint :
- Ease of implantation.
- Stability of device within the eye
Secondary Performance Endpoints -:
IOL stability, centration and tilt, visual acuity
Study Group:
A single study group. This is a single arm design; there is no control device in this study.
Key Inclusion Criteria:
Subject requires capsule centration. Subject is between 18 and 100 years of age Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Key Exclusion Criteria:
Subject is diagnosed with active anterior segment intraocular inflammation Subject is obligated to previous participation in another study with any investigational drug or device within the past 30 days Subject is pregnant
Visits \& Procedures Pre-operative visit: 0-1 month prior the implantation procedure. The visit will include subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including subject's medical complaints, medical history, medication use and ophthalmic examinations, family history and any detail relevant to the cause of lens malposition Surgical procedure: Procedure will be performed under anesthesia (at physician discretion) and the modified AssiAnchor will be implanted.
Follow-up: All subjects will have regularly follow-up visits up to 3 months post-implantation. All postoperative visits will include a complete ophthalmic examinations, medications used and recording of adverse events.
- Conditions
- Cataract
- Being tested
- AssiAnchor
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssiAnchorDevice
The novel device, the capsular "Anchor", was designed to secure the capsular bag to the scleral wall. The device is a one-piece, one-plane intraocular implant . It works like a paper clip; holding the anterior capsule between a central rod, placed in front of the capsule, and the two lateral arms, inserted through the eye surgery and placed behind the capsule.
| Study group | Role | What they receive |
|---|---|---|
| capsular fixation surgery | Experimental | patients required capsule centration safely undergo capsular fixation surgery with AssiAnchor under local anesthesia . Receives: Device: AssiAnchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the new AssiAnchor.
Stability of device with in the eye will be assessed
Measured: 1 year
performance of the new AssiAnchor.
We will assess if implantation of AssiAnchor
- Enables cataract surgery for subluxated lens
- Centers subluxated capsule
- Provides a wide contact between the device and the anterior capsule
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start24 Mar 2018
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455114
- Sponsor's protocol ID
- AssiAnchor-02
- Acronym
- cataracts
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2018
- Last updated
- 2 Mar 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 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
- ClinicalTrials.gov ID
- NCT03455114
- Acronym / sponsor ID
- cataracts / AssiAnchor-02
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 6 Mar 2018 (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 AssiAnchor 2 is a fixation ophthalmic device. The device is manufactured by Hanita Lenses from PMMA material which is being used for the production of Intra-ocular lenses.
The device is intended for patients requiring capsule centration to clip the anterior lens capsule between the arms of the device and secure it to the scleral wall.
Detailed description
Intended Use:
The AssiAnchor is a device which is intended to be implanted permanently in the posterior chamber of the eye for fixation of subluxated capsule.
Study Objectives:
The primary aim of this study is to assess the safety and performance of the new AssiAnchor. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period.
Study population:
Men and women diagnosed with subluxated capsular bag that require lens removal surgery or in malpositioned pseudophakia that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 10 subjects will be enrolled.
Investigational sites:
One (1) center will participate in this study.
Duration of Subject participation:
Completion of active enrolment is anticipated to last approximately 12 months. The objectives of this study will be achieved when the final study subject has completed 3 months follow-up.
Primary Safety Endpoint :
- Ease of implantation.
- Stability of device within the eye
Secondary Performance Endpoints -:
IOL stability, centration and tilt, visual acuity
Study Group:
A single study group. This is a single arm design; there is no control device in this study.
Key Inclusion Criteria:
Subject requires capsule centration. Subject is between 18 and 100 years of age Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Key Exclusion Criteria:
Subject is diagnosed with active anterior segment intraocular inflammation Subject is obligated to previous participation in another study with any investigational drug or device within the past 30 days Subject is pregnant
Visits \& Procedures Pre-operative visit: 0-1 month prior the implantation procedure. The visit will include subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including subject's medical complaints, medical history, medication use and ophthalmic examinations, family history and any detail relevant to the cause of lens malposition Surgical procedure: Procedure will be performed under anesthesia (at physician discretion) and the modified AssiAnchor will be implanted.
Follow-up: All subjects will have regularly follow-up visits up to 3 months post-implantation. All postoperative visits will include a complete ophthalmic examinations, medications used and recording of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsular fixation surgery | Experimental | Device: AssiAnchorpatients required capsule centration safely undergo capsular fixation surgery with AssiAnchor under local anesthesia . |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Requires capsule centration during or after cataract surgery.
- Understands the study requirements and the treatment procedures
- Sign Informed Consent before any study-specific tests or procedures.
Key exclusion criteria (3 listed)
- Diagnosed with active anterior segment intraocular inflammation.
- Obligated to participation in another clinical study within the past 30 days.
- Pregnant.
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 |
|---|---|---|
| AssiAnchorThe novel device, the capsular "Anchor", was designed to secure the capsular bag to the scleral wall. The device is a one-piece, one-plane intraocular implant . It works like a paper clip; holding the anterior capsule between a central rod, placed in front of the capsule, and the two lateral arms, inserted through the eye surgery and placed behind the capsule. | Device | capsular fixation surgery |
Primary outcome
Safety of the new AssiAnchor.
Time frame: 1 year
Stability of device with in the eye will be assessed
performance of the new AssiAnchor.
Time frame: 1 year
We will assess if implantation of AssiAnchor * Enables cataract surgery for subluxated lens * Centers subluxated capsule * Provides a wide contact between the device and the anterior capsule
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 2 Mar 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 AssiAnchor in people with Cataract, run by Hanita Lenses at 1 site in Israel.
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 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 2 Mar 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 Israel. 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?
Safety of the new AssiAnchor. (time frame: 1 year). 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 2 Mar 2022.