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Influence of CleaRing Open-capsule Device on Refractive Predictability in Cataract Patients (Part 2)

Israel25 participantsStarted 2023-04-15

Plain-language 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. The device is manufactured by Hanita Lenses from a hydrophilic acrylic co-polymer which is being used for the production of Intra-ocular lenses.

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The first primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.

Timeframe: 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.

Timeframe: 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.

Timeframe: 1, 3 and 5 years

Trial details

NCT IDNCT06083025

SponsorHanita Lenses

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-01

Contact for this trial

Inbal Ratner

035028702 inbalr@wmc.gov.il

View on ClinicalTrials.gov More Posterior Capsule Opacification trials

Plain-language summary

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The first primary objective of this study is to evaluate the influence of Clearing open-capsule device on refractive predictability in cataract patients.

Timeframe: 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.

Timeframe: 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.

Timeframe: 1, 3 and 5 years