CataractNCT04838730
Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients
A study testing Surgical procedure in people with Cataract, run by Hanita Lenses at 1 site in Israel.
Trial summary
CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Surgical procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2019to 1 Jan 2023
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is between 50 and 80 years of age The subject is designated for cataract surgery
- Eye designated for the study fulfills the following criteria:
- Potentially able to achieve a good vision (by the opinion of the investigator)
- ACD is at least 2.5mm (from epithelium)
- Corneal astigmatism is at most 2.0 DPT
- Axial length is between 22.0 and 26.0 mm
- Able to obtain pupil dilation of at least 6.0 mm
- Average keratometry values between 42.0 and 46.0 D Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Who cannot join
- Subject diagnosed with glaucoma of any type or having intraocular pressure above 24mmHg
- Subject who has undergone previous intraocular surgery in eye designated for the study
- Subject with a corneal abnormality that would prevent stable and reliable refraction
- Subject with weak or torn zonules
- Subject with Pseudoexfoliation syndrome (PEX)
- Subject with amblyopia
Show all 10Show fewer
- Subject with a retinal disease that in the opinion of the principal investigator would prevent stable and reliable refraction or might be worsened due to implantation of the device
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson
Holon
Inbal Ratner, INBALR@wmc.gov.il
About this study
CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery.
Read the detailed description
Study Design:
This study is a prospective, single-group, single-center, open-label study. Each study subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye.
Study population:
Men and women designated for cataract surgery that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 20 subjects will be enrolled.
Investigational sites:
Single-center study.
Duration of Subject participation:
The primary endpoint will be achieved when the study subject has completed a 1-month follow-up after the implantation of the CleaRing device.
Study Group:
Each subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye.
Visits \& Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including the subject's medical complaints, medical history, medication use, and ophthalmic examinations.
Surgical procedure: Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.
Follow-up: All subjects will have regular follow-up visits at the following post-operative periods: 1 day, 7 days, and 1 month. All postoperative visits will include a complete ophthalmic examination, a record of medications used, and documentation of adverse events.
- Conditions
- Cataract
- Being tested
- Surgical procedure
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical procedureDevice
Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Hanita CleaRing device (CE approved; AMAR Certificate) Receives: Device: Surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ACUITY
Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be done with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms.
Visual acuity will be measured with either Snellen or ETDRS format charts for distance.
Results will be recorded in a LogMar scale.
Measured: 1 month
SLIT LAMP EXAM
The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion, degree of posterior capsular opacification and correct position of the IOL and the CleaRing device.
For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading:
Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = > 30 cells seen
Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance.
Measured: 1 month
MEASUREMENT OF INTRAOCULAR PRESSURE
Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838730
- Sponsor's protocol ID
- CR-0719
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2021
- Last updated
- 9 Apr 2021
- 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients
- ClinicalTrials.gov ID
- NCT04838730
- Acronym / sponsor ID
- CR-0719
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 9 Apr 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.
CleaRing is intended to reduce posterior capsular opacification in cataract patients. The device is intended to be implanted together with standard posterior chamber IOL during cataract surgery.
Detailed description
Study Design:
This study is a prospective, single-group, single-center, open-label study. Each study subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye.
Study population:
Men and women designated for cataract surgery that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.
Enrollment:
A total of 20 subjects will be enrolled.
Investigational sites:
Single-center study.
Duration of Subject participation:
The primary endpoint will be achieved when the study subject has completed a 1-month follow-up after the implantation of the CleaRing device.
Study Group:
Each subject will be implanted with a CleaRing device together with SeeLens AF IOL in a single eye.
Visits \& Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.
Complete anamnesis will be taken including the subject's medical complaints, medical history, medication use, and ophthalmic examinations.
Surgical procedure: Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.
Follow-up: All subjects will have regular follow-up visits at the following post-operative periods: 1 day, 7 days, and 1 month. All postoperative visits will include a complete ophthalmic examination, a record of medications used, and documentation 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 |
|---|---|---|
| single-arm | Experimental | Device: Surgical procedureHanita CleaRing device (CE approved; AMAR Certificate) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is between 50 and 80 years of age The subject is designated for cataract surgery
- Potentially able to achieve a good vision (by the opinion of the investigator)
- ACD is at least 2.5mm (from epithelium)
- Corneal astigmatism is at most 2.0 DPT
- Axial length is between 22.0 and 26.0 mm
Key exclusion criteria (10 listed)
- Subject diagnosed with glaucoma of any type or having intraocular pressure above 24mmHg
- Subject who has undergone previous intraocular surgery in eye designated for the study
- Subject with a corneal abnormality that would prevent stable and reliable refraction
- Subject with weak or torn zonules
- Subject with Pseudoexfoliation syndrome (PEX)
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 |
|---|---|---|
| Surgical procedureStandard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL. | Device | single-arm |
Primary outcome
VISUAL ACUITY
Time frame: 1 month
Distance (far) manifest refraction and the testing distance used will be recorded on the case report forms. Manifest refraction will be determined using the maximum plus for best visual acuity method. The distance manifest refraction will be done with a distance adjusted chart but not less than 4 meters. The actual manifest refraction distance will be noted on the case report forms. Visual acuity will be measured with either Snellen or ETDRS format charts for distance. Results will be recorded in a LogMar scale.
SLIT LAMP EXAM
Time frame: 1 month
The slit lamp exam will include the measurement of aqueous cell and flare, and the measurement of corneal edema by a standard grading system. It will also include an evaluation for the presence of pupillary irregularities, iris atrophy and pigment dispersion, degree of posterior capsular opacification and correct position of the IOL and the CleaRing device. For the evaluation of aqueous cells and flare, use a slit lamp beam 0.3 mm wide and 1 mm high, and use the following grading: Cells none (0) = no cells seen trace (+1) = 1-5 cells seen mild (+2) = 6-15 cells seen moderate (+3) = 16-30 cells seen severe (+4) = > 30 cells seen Flare none (0) = No Tyndall effect trace (+1) = Tyndall effect barely discernible mild (+2) = Tyndall beam in anterior chamber is mildly intense moderate (+3) = Tyndall beam in anterior chamber is moderately intense severe (+4) = Tyndall beam is severely intense. The aqueous has a white and milky appearance.
MEASUREMENT OF INTRAOCULAR PRESSURE
Time frame: 1 month
Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical procedure 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inbal Ratner (0526505531, INBALR@wmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISUAL ACUITY (time frame: 1 month). The study lists 3 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 9 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.