Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical and 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: July 18, 2013
Last verified: June 2013
  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

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 and Literature Controls.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Best Spectacle-Corrected (ETDRS) Distance Visual Acuity compared to historical and literature controls [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications and Adverse Events comparable to historical and literature controls [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
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: 1 Device: iSert 251
iSert 251 intraocular lens

  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: James Wartman 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
Last Updated: July 18, 2013
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

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 23, 2014