Posterior Capsule OpacificationCleaRingNCT06083025
Influence of CleaRing Open-capsule Device on Refractive Predictability in Cataract Patients (Part 2)
A study testing CleaRing in people with Posterior Capsule Opacification, run by Hanita Lenses at 1 site in Israel.
Trial summary
The Hanita CleaRing device is an intraocular implant designed for inhibition of PCO leading to reduction in the Nd:YAG treatment rate. The device is implanted into the capsular bag after the extraction of the crystalline lens and prior to implantation of the IOL. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Posterior Capsule Opacification
- What is being tested?
- CleaRing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Apr 2023to 1 Apr 2025
- 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
- Subject is between 50 and 80 years of age
- Subject is designated for bilateral cataract surgery
- Both eyes fulfil the following criteria:
- Potentially able to achieve a good vision (by opinion of the investigator)
- ACD is at least 2.5mm (from epithelium)
- Corneal astigmatism is at most 2.0 dpt
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- 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
- Subject with corneal abnormality that would prevent stable and reliable refraction
- Subject with weak or torn zonules
- Subject with Pseudoexfoliation syndrome (PEX)
- Subject with amblyopia
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- Subject with 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 Medical Center
Holon, Tel Aviv
Inbal Ratner, 035028702 ext. +972, inbalr@wmc.gov.il
Guy Kleinmann, Prof.
About this study
The Hanita CleaRing device is an intraocular implant designed for inhibition of PCO leading to reduction in the Nd:YAG treatment rate. The device is implanted into the capsular bag after the extraction of the crystalline lens and prior to implantation of the IOL. The device is manufactured by Hanita Lenses from a hydrophilic acrylic co-polymer which is being used for the production of Intra-ocular lenses.
Read the detailed description
Cataract surgery has undergone significant improvement in terms of surgical technique, instrumentation and the quality of intraocular lenses (IOLs) over the past decades. Although the rate of posterior capsular opacification (PCO) has decreased, it is still the most common complication following uneventful cataract surgery, with the rate of laser capsulotomy ranging from 10% to 37%1-5 ND:YAG capsulotomy is a highly successful treatment, but it is not free of complications, such as increased intraocular pressure (IOP), pitting or dislocation of the IOL, cystoid macular edema, and retinal detachment. PCO also places an economic burden on the healthcare system. The importance of PCO prevention has increased in recent years, due to the expanding popularity of premium IOLs. Patients implanted with a premium IOL usually have high demands with regard to outcome, and PCO can also have an earlier effect on the performance of a premium IOL (i.e., multifocal IOLs).
Previous attempts to prevent PCO have included investigations of various IOL materials and designs, surgical techniques, and pharmacological materials. Unexpectedly lower PCO rates were recently noticed in eyes that were implanted with a special type of IOL, e.g., the Synchrony IOL (AMO, Santa Ana, CA, USA)8 and the FluidVision IOL (PowerVision, Belmont, CA, USA). It was hypothesized that the capsular bag stayed open due to the special design of these IOLs, and that this should reduce the PCO rate. Based upon this concept, a special open capsule ring was designed for intracapsular implantation in an attempt to maintain the capsular bag open and to reduce PCO rate. Safety and efficacy of the device was demonstrated through several animal studies. The tested devices were effective in reducing posterior capsule opacification and Soemmering's ring formation by 69% to 77% compared to control group. The Hanita CleaRing device is designed to be implanted in the capsular bag together with a standard posterior chamber IOL in a minimally invasive cataract surgery. The device is intended to reduce posterior capsular opacification leading to reduced Nd:YAG treatment rate. The raw material of the device is a hydrophilic co-polymer, considered to be biocompatible and practically inert to the eye tissue. The objective of this study is to evaluate the safety and the efficacy of CleaRing device in cataract patients.
- Conditions
- Posterior Capsule Opacification
- Being tested
- CleaRing
- Keywords
- Posterior capsule opacification, Cataract, Ring
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleaRingDevice
The Hanita CleaRing device is an intraocular implant designed for inhibition of PCO leading to reduction in the Nd:YAG treatment rate. The device is implanted into the capsular bag after the extraction of the crystalline lens and prior to implantation of the IOL. The device is manufactured by Hanita Lenses from a hydrophilic acrylic co-polymer which is being used for the production of Intra-ocular lenses.
| Study group | Role | What they receive |
|---|---|---|
| CleaRing device for cataract patients | Experimental | All subjects who meet eligibility requirements will be asked to participate. Subjects will be considered enrolled into the study after:
1. A signed Informed Consent has been obtained.
2. The subject has met all of the inclusion and none of the exclusion criteria.
3. The ability of the subject to safely undergo cataract surgery under local anesthesia was confirmed by the investigator, according to standard procedure of the medical center. Receives: Device: CleaRing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.
Refractive will be evaluated by Automated refraction
Measured: 1, 3 and 5 years
The second primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.
Refractive will be evaluated by subjective refraction
Measured: 1, 3 and 5 years
The third primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.
Refractive will be evaluated by visual acuity measurement.
Measured: 1, 3 and 5 years
Secondary outcomes (1)
Secondary objective of this study is to evaluate the influence of the device on PCO rate
PCO will be evaluated by using Biomicroscopy (Slit Lamp)
Measured: 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start15 Apr 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Capsule OpacificationStudies 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
- Model description
- This study is a prospective, single group, single center, open label study. Each study subject will be implanted bilaterally with IOL of surgeon's choice (same IOL in both eyes) and CleaRing device in one eye.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanita Lenses
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Kleinmann, Prof., Principal investigator, Wolfson MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083025
- Sponsor's protocol ID
- CR-0719 Part 2
- Acronym
- CleaRing
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 13 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 13 Oct 2023. 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 (Part 2)
- ClinicalTrials.gov ID
- NCT06083025
- Acronym / sponsor ID
- CleaRing / CR-0719 Part 2
- Conditions
- Posterior Capsule Opacification
- Keywords
- Posterior capsule opacification, Cataract, Ring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hanita LensesIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 13 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.
The Hanita CleaRing device is an intraocular implant designed for inhibition of PCO leading to reduction in the Nd:YAG treatment rate. The device is implanted into the capsular bag after the extraction of the crystalline lens and prior to implantation of the IOL. The device is manufactured by Hanita Lenses from a hydrophilic acrylic co-polymer which is being used for the production of Intra-ocular lenses.
Detailed description
Cataract surgery has undergone significant improvement in terms of surgical technique, instrumentation and the quality of intraocular lenses (IOLs) over the past decades. Although the rate of posterior capsular opacification (PCO) has decreased, it is still the most common complication following uneventful cataract surgery, with the rate of laser capsulotomy ranging from 10% to 37%1-5 ND:YAG capsulotomy is a highly successful treatment, but it is not free of complications, such as increased intraocular pressure (IOP), pitting or dislocation of the IOL, cystoid macular edema, and retinal detachment. PCO also places an economic burden on the healthcare system. The importance of PCO prevention has increased in recent years, due to the expanding popularity of premium IOLs. Patients implanted with a premium IOL usually have high demands with regard to outcome, and PCO can also have an earlier effect on the performance of a premium IOL (i.e., multifocal IOLs).
Previous attempts to prevent PCO have included investigations of various IOL materials and designs, surgical techniques, and pharmacological materials. Unexpectedly lower PCO rates were recently noticed in eyes that were implanted with a special type of IOL, e.g., the Synchrony IOL (AMO, Santa Ana, CA, USA)8 and the FluidVision IOL (PowerVision, Belmont, CA, USA). It was hypothesized that the capsular bag stayed open due to the special design of these IOLs, and that this should reduce the PCO rate. Based upon this concept, a special open capsule ring was designed for intracapsular implantation in an attempt to maintain the capsular bag open and to reduce PCO rate. Safety and efficacy of the device was demonstrated through several animal studies. The tested devices were effective in reducing posterior capsule opacification and Soemmering's ring formation by 69% to 77% compared to control group. The Hanita CleaRing device is designed to be implanted in the capsular bag together with a standard posterior chamber IOL in a minimally invasive cataract surgery. The device is intended to reduce posterior capsular opacification leading to reduced Nd:YAG treatment rate. The raw material of the device is a hydrophilic co-polymer, considered to be biocompatible and practically inert to the eye tissue. The objective of this study is to evaluate the safety and the efficacy of CleaRing device in cataract patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, single group, single center, open label study. Each study subject will be implanted bilaterally with IOL of surgeon's choice (same IOL in both eyes) and CleaRing device in one eye.
| Arm | Type | Receives |
|---|---|---|
| CleaRing device for cataract patients | Experimental | Device: CleaRingAll subjects who meet eligibility requirements will be asked to participate. Subjects will be considered enrolled into the study after: 1. A signed Informed Consent has been obtained. 2. The subject has met all of the inclusion and none of the exclusion criteria. 3. The ability of the subject to safely undergo cataract surgery under local anesthesia was confirmed by the investigator, according to standard procedure of the medical center. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is between 50 and 80 years of age
- Subject is designated for bilateral cataract surgery
- Both eyes fulfil the following criteria:
- 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 (10 listed)
- Subject diagnosed with glaucoma of any type or having intraocular pressure above 24mmHg
- Subject who has undergone previous intraocular surgery
- Subject with 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 |
|---|---|---|
| CleaRingThe Hanita CleaRing device is an intraocular implant designed for inhibition of PCO leading to reduction in the Nd:YAG treatment rate. The device is implanted into the capsular bag after the extraction of the crystalline lens and prior to implantation of the IOL. The device is manufactured by Hanita Lenses from a hydrophilic acrylic co-polymer which is being used for the production of Intra-ocular lenses. | Device | CleaRing device for cataract patients |
Primary outcome
The first primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.
Time frame: 1, 3 and 5 years
Refractive will be evaluated by Automated refraction
The second primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.
Time frame: 1, 3 and 5 years
Refractive will be evaluated by subjective refraction
The third primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.
Time frame: 1, 3 and 5 years
Refractive will be evaluated by visual acuity measurement.
1 secondary outcome
Secondary objective of this study is to evaluate the influence of the device on PCO rate
Time frame: 1, 3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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.
Guy Kleinmann, Prof. principal investigator
Wolfson MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CleaRing in people with Posterior Capsule Opacification, 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 10 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 13 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 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 (035028702 ext. +972, inbalr@wmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients. (time frame: 1, 3 and 5 years). 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 13 Oct 2023.