Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    20
  • sponsor
    Hanita Lenses
Updated on 18 April 2021

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.

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.

Details
Condition Cataract, Cataracts, Cataracts
Treatment surgical procedure
Clinical Study IdentifierNCT04838730
SponsorHanita Lenses
Last Modified on18 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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