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

NCT04838730 | Unknown

• 1 other identifier: CR-0719
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  1 month

• MEASUREMENT OF INTRAOCULAR PRESSURE

  Intraocular pressure will be measured using Goldmann applanation tonometry or other validated methods.

  1 month

Study Arms (1)

single-arm

EXPERIMENTAL

Hanita CleaRing device (CE approved; AMAR Certificate)

Device: Surgical procedure

Interventions

Surgical procedure DEVICE

Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.

single-arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanita Lenses: lead

Study Sites (1)

Wolfson

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Inbal Ratner

CONTACT

0526505531; INBALR@wmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: April 9, 2021
• Study Start: January 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

IL (1)