A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

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.
    

Intervention name(s): AssiAnchor
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment