Clinical trial NCT04838730: Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients
Official title: Influence of Clearing Open-capsule Device on Refractive Predictability in Cataract Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

1. Subject diagnosed with glaucoma of any type or having intraocular pressure above 24mmHg
2. Subject who has undergone previous intraocular surgery in eye designated for the study
3. Subject with a corneal abnormality that would prevent stable and reliable refraction
4. Subject with weak or torn zonules
5. Subject with Pseudoexfoliation syndrome (PEX)
6. Subject with amblyopia
7. 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
8. Subject is diagnosed with active anterior segment intraocular inflammation
9. Subject is obligated to previous participation in another study with any investigational drug or device within the past 30 days
10. Subject is pregnant

Primary outcomes:
measure: VISUAL ACUITY
timeFrame: 1 month
measure: SLIT LAMP EXAM
timeFrame: 1 month
measure: MEASUREMENT OF INTRAOCULAR PRESSURE
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson
Study officials:
References: