Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Primary Purpose
Aphakia, Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iSert 251 intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring intraocular lens, IOL, cataract, Hoya, surgical, optics, ocular, visual acuity
Eligibility Criteria
Inclusion Criteria:
- Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
- Have clear intraocular media
- Have potential Best Corrected Visual Acuity of 20/40 or better
- Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse
Exclusion Criteria:
- Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
- Are monocular
- Have current ocular infection
- Are taking systemic steroids or other anti-metabolites
- Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Sites / Locations
- Schwartz Laser Eye Center
- Katzen Eye Care and Laser Center
- Center for Excellence in Eye Care
- Eye Surgeons of Indiana
- Eye Health Vision Centers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational intraocular lens
Arm Description
iSert 251 intraocular lens
Outcomes
Primary Outcome Measures
Visual Acuity
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Secondary Outcome Measures
Complications and Adverse Events
Number of Participants with Complications or Adverse Events
Full Information
NCT ID
NCT01292629
First Posted
February 4, 2011
Last Updated
March 18, 2015
Sponsor
Hoya Surgical Optics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01292629
Brief Title
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Official Title
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoya Surgical Optics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
Detailed Description
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
intraocular lens, IOL, cataract, Hoya, surgical, optics, ocular, visual acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational intraocular lens
Arm Type
Experimental
Arm Description
iSert 251 intraocular lens
Intervention Type
Device
Intervention Name(s)
iSert 251 intraocular lens
Intervention Description
aphakic intraocular lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Time Frame
4 to 6 months
Secondary Outcome Measure Information:
Title
Complications and Adverse Events
Description
Number of Participants with Complications or Adverse Events
Time Frame
4 to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
Have clear intraocular media
Have potential Best Corrected Visual Acuity of 20/40 or better
Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse
Exclusion Criteria:
Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
Are monocular
Have current ocular infection
Are taking systemic steroids or other anti-metabolites
Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kees den Besten
Organizational Affiliation
Hoya Surgical Optics
Official's Role
Study Director
Facility Information:
Facility Name
Schwartz Laser Eye Center
City
E. Shea Blvd, Suite C101
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Katzen Eye Care and Laser Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Eye Health Vision Centers
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
We'll reach out to this number within 24 hrs