Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01292629
First received: February 4, 2011
Last updated: March 18, 2015
Last verified: March 2015
  Purpose

The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.


Condition Intervention
Aphakia
Cataract
Device: iSert 251 intraocular lens

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

Resource links provided by NLM:


Further study details as provided by Hoya Surgical Optics, Inc.:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    BEST Spectacle-Correction (ETDRS) Distance Visual Acuity


Secondary Outcome Measures:
  • Complications and Adverse Events [ Time Frame: 4 to 6 months ] [ Designated as safety issue: Yes ]
    Number of Participants with Complications or Adverse Events


Enrollment: 125
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational intraocular lens
iSert 251 intraocular lens
Device: iSert 251 intraocular lens
aphakic intraocular lens

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292629

Locations
United States, Arizona
Schwartz Laser Eye Center
E. Shea Blvd, Suite C101, Arizona, United States, 85260
United States, Florida
Katzen Eye Care and Laser Center
Boynton Beach, Florida, United States, 33426
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Massachusetts
Eye Health Vision Centers
North Dartmouth, Massachusetts, United States, 02747
Sponsors and Collaborators
Hoya Surgical Optics, Inc.
Investigators
Study Director: Kees den Besten Hoya Surgical Optics
  More Information

No publications provided

Responsible Party: Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier: NCT01292629     History of Changes
Other Study ID Numbers: 2010-N251
Study First Received: February 4, 2011
Results First Received: February 11, 2015
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoya Surgical Optics, Inc.:
intraocular lens
IOL
cataract
Hoya
surgical
optics
ocular
visual acuity

ClinicalTrials.gov processed this record on August 02, 2015