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Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical and Literature Controls.

This study is currently recruiting participants.
Verified October 2012 by Hoya Surgical Optics, Inc.
Sponsor:
Information provided by:
Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01292629
First received: February 4, 2011
Last updated: October 26, 2012
Last verified: October 2012
History of Changes

February 4, 2011
October 26, 2012
February 2011
November 2012   (final data collection date for primary outcome measure)
Best Spectacle-Corrected (ETDRS) Distance Visual Acuity compared to historical and literature controls [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01292629 on ClinicalTrials.gov Archive Site
Complications and Adverse Events comparable to historical and literature controls [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical and Literature Controls.
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical and Literature Controls.

The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aphakia
  • Cataract
Device: iSert 251
iSert 251 intraocular lens
Experimental: 1
Intervention: Device: iSert 251
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: James Wartman 909-680-3900 james.wartman@hoya.com
United States
 
NCT01292629
2010-N251
Not Provided
James Wartman/ Sr. Director of Global Regulatory Affairs and QA, Hoya Surgical Optics, Inc.
Hoya Surgical Optics, Inc.
Not Provided
Study Director: James Wartman Hoya Surgical Optics
Hoya Surgical Optics, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP