Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

February 4, 2011
March 18, 2015
February 2011
May 2012   (final data collection date for primary outcome measure)
Visual Acuity [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
Best Spectacle-Corrected (ETDRS) Distance Visual Acuity compared to historical and literature controls [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01292629 on ClinicalTrials.gov Archive Site
Complications and Adverse Events [ Time Frame: 4 to 6 months ] [ Designated as safety issue: Yes ]
Number of Participants with Complications or Adverse Events
Complications and Adverse Events comparable to historical and literature controls [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / 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.
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aphakia
  • Cataract
Device: iSert 251 intraocular lens
aphakic intraocular lens
Experimental: Investigational intraocular lens
iSert 251 intraocular lens
Intervention: Device: iSert 251 intraocular lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
May 2012
May 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01292629
2010-N251
No
Not Provided
Not Provided
Hoya Surgical Optics, Inc.
Hoya Surgical Optics, Inc.
Not Provided
Study Director: Kees den Besten Hoya Surgical Optics
Hoya Surgical Optics, Inc.
March 2015

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