Clinical trial NCT03455114: A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
Official title: A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Hanita Lenses
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Intended Use:

The AssiAnchor is a device which is intended to be implanted permanently in the posterior chamber of the eye for fixation of subluxated capsule.

Study Objectives:

The primary aim of this study is to assess the safety and performance of the new AssiAnchor. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period.

Study population:

Men and women diagnosed with subluxated capsular bag that require lens removal surgery or in malpositioned pseudophakia that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study.

Enrollment:

A total of 10 subjects will be enrolled.

Investigational sites:

One (1) center will participate in this study.

Duration of Subject participation:

Completion of active enrolment is anticipated to last approximately 12 months. The objectives of this study will be achieved when the final study subject has completed 3 months follow-up.

Primary Safety Endpoint :

* Ease of implantation.
* Stability of device within the eye

Secondary Performance Endpoints -:

IOL stability, centration and tilt, visual acuity

Study Group:

A single study group. This is a single arm design; there is no control device in this study.

Key Inclusion Criteria:

Subject requires capsule centration. Subject is between 18 and 100 years of age Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

Key Exclusion Criteria:

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

Visits \& Procedures Pre-operative visit: 0-1 month prior the implantation procedure. The visit will include subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed.

Complete anamnesis will be taken including subject's medical complaints, medical history, medication use and ophthalmic examinations, family history and any detail relevant to the cause of lens malposition Surgical procedure: Procedure will be performed under anesthesia (at physician discretion) and the modified AssiAnchor will be implanted.

Follow-up: All subjects will have regularly follow-up visits up to 3 months post-implantation. All postoperative visits will include a complete ophthalmic examinations, medications used and recording of adverse events.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Safety of the new AssiAnchor.
timeFrame: 1 year
measure: performance of the new AssiAnchor.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: MeirMC
Study officials:
References: