Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
Primary Purpose
Aphakia
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Artisan Aphakia Intraocular Lens
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring aphakia, secondary intraocular lens
Eligibility Criteria
Inclusion Criteria:
- Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
- Patient must agree to comply with the visit schedule and other requirements of the study
Exclusion Criteria:
- Patients that are not able to meet the extensive postoperative evaluation requirements
- Mentally retarded patients
- When the patient has no useful vision or vision potential in the fellow eye
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
- Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
- Patients with uncontrolled glaucoma
- High preoperative intraocular pressure, >25 mmHg
- Chronic or recurrent uveitis or history of the same
- Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
- Patients with a retinal detachment or a family history of retinal detachment
- Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
- Diabetes mellitus
- Pregnant, lactating, or plans to become pregnant during the course of this study
Sites / Locations
- Assil Eye InstituteRecruiting
- Advanced Vision CareRecruiting
- Yale Medicine Ophthalmology
- Price Vision GroupRecruiting
- John Kenyon Eye CenterRecruiting
- Boston Children's HospitalRecruiting
- Rosenthal Eye and Facial Plastic Surgery
- Pamel Vision and Laser Group
- New York Medical College, Westchester Medical CenterRecruiting
- Nevyas Eye AssociatesRecruiting
- Vance Thompson VisionRecruiting
- University of Tennessee, Hamilton Eye ClinicRecruiting
- Focal Point VisionRecruiting
- Moran Eye CenterRecruiting
- Valley Eye AssociatesRecruiting
- Prism Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraocular Lens Implantation for the Treatment for Aphakia
Arm Description
Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section
Outcomes
Primary Outcome Measures
Improvement in best corrected visual acuity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01547429
Brief Title
Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
Official Title
Artisan Aphakia Lens for the Correction of Aphakia in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophtec USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine the safety and effectiveness of the Artisan Aphakia Lens when used as a secondary implant to correct aphakia in adults.
Detailed Description
Not desired
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
Keywords
aphakia, secondary intraocular lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraocular Lens Implantation for the Treatment for Aphakia
Arm Type
Experimental
Arm Description
Implantation of an Artisan intraocular lens to correct aphakia in Adults. No other information is needed to describe this section
Intervention Type
Device
Intervention Name(s)
Artisan Aphakia Intraocular Lens
Intervention Description
Implantation of lens to correct refractive error in aphakic eye
Primary Outcome Measure Information:
Title
Improvement in best corrected visual acuity
Time Frame
3 year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients 22 years of age and over at baseline visit of either sex and of any race where the natural lens has been removed or will be removed and a posterior chamber IOL is not indicated.
Patient must agree to comply with the visit schedule and other requirements of the study
Exclusion Criteria:
Patients that are not able to meet the extensive postoperative evaluation requirements
Mentally retarded patients
When the patient has no useful vision or vision potential in the fellow eye
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.), corneal dystrophy, degeneration, opacities or abnormalities that may affect vision.
Abnormality of the iris or ocular structure which would preclude fixation, such as aniridia, hemiiridectomy, severe iris atrophy, rubeosis iridis, or other compromising iris pathology
Patients with uncontrolled glaucoma
High preoperative intraocular pressure, >25 mmHg
Chronic or recurrent uveitis or history of the same
Preexisting macular pathology that may complicate the ability to assess the benefit or lack of benefit obtained by the lens
Patients with a retinal detachment or a family history of retinal detachment
Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity or Stargardt's retinopathy Optic nerve disease that may limit the visual potential of the eye
Diabetes mellitus
Pregnant, lactating, or plans to become pregnant during the course of this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abraham Farahan
Phone
561-989-8767
Email
abraham.farhan@usa.ophtec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Farhan
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Assil Eye Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Vision Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Medicine Ophthalmology
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06614
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
John Kenyon Eye Center
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Rosenthal Eye and Facial Plastic Surgery
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Individual Site Status
Suspended
Facility Name
Pamel Vision and Laser Group
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Suspended
Facility Name
New York Medical College, Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Name
Nevyas Eye Associates
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee, Hamilton Eye Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Individual Site Status
Recruiting
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Eye Associates
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54914
Country
United States
Individual Site Status
Recruiting
Facility Name
Prism Eye Institute
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 1W8
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Artisan Aphakia Lens for the Correction of Aphakia (Secondary) in Adults
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