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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
Hoya Surgical Optics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 4, 2011
Last Updated
March 18, 2015
Sponsor
Hoya Surgical Optics, Inc.
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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.

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