NCT03455114

Brief Summary

The AssiAnchor 2 is a fixation ophthalmic device. The device is manufactured by Hanita Lenses from PMMA material which is being used for the production of Intra-ocular lenses. The device is intended for patients requiring capsule centration to clip the anterior lens capsule between the arms of the device and secure it to the scleral wall.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

March 24, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

February 11, 2018

Last Update Submit

February 26, 2022

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

  • Safety of the new AssiAnchor.

    Stability of device with in the eye will be assessed

    1 year

  • performance of the new AssiAnchor.

    We will assess if implantation of AssiAnchor * Enables cataract surgery for subluxated lens * Centers subluxated capsule * Provides a wide contact between the device and the anterior capsule

    1 year

Study Arms (1)

capsular fixation surgery

EXPERIMENTAL

patients required capsule centration safely undergo capsular fixation surgery with AssiAnchor under local anesthesia .

Device: AssiAnchor

Interventions

AssiAnchorDEVICE

The novel device, the capsular "Anchor", was designed to secure the capsular bag to the scleral wall. The device is a one-piece, one-plane intraocular implant . It works like a paper clip; holding the anterior capsule between a central rod, placed in front of the capsule, and the two lateral arms, inserted through the eye surgery and placed behind the capsule.

capsular fixation surgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requires capsule centration during or after cataract surgery.
  • Understands the study requirements and the treatment procedures
  • Sign Informed Consent before any study-specific tests or procedures.

You may not qualify if:

  • Diagnosed with active anterior segment intraocular inflammation.
  • Obligated to participation in another clinical study within the past 30 days.
  • Pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MeirMC

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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

February 11, 2018

First Posted

March 6, 2018

Study Start

March 24, 2018

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

IL(1)