Ignite Creation Date:
2025-12-18 @ 9:50 AM
Ignite Modification Date:
2025-12-23 @ 10:51 PM
Study NCT ID:
NCT03455114
Status:
None
Last Update Posted:
2022-03-02 00:00:00
First Post:
2018-02-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
Sponsor:
None
Organization:
Study Overview
Official Title:
A Single-arm, Open-label Feasibility Study for Assessing the Safety and Performance of the Modified AssiAnchor
Status:
None
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
cataracts
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: