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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292629
• Other study ID #: 2010-N251
• Status: Completed
• Phase: N/A
• First received: February 4, 2011
• Last updated: March 18, 2015
• Start date: February 2011
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Hoya Surgical Optics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Device:
• iSert 251 intraocular lens
aphakic intraocular lens

Locations

Country	Name	City	State
United States	Katzen Eye Care and Laser Center	Boynton Beach	Florida
United States	Schwartz Laser Eye Center	E. Shea Blvd, Suite C101	Arizona
United States	Eye Surgeons of Indiana	Indianapolis	Indiana
United States	Center for Excellence in Eye Care	Miami	Florida
United States	Eye Health Vision Centers	North Dartmouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Hoya Surgical Optics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	BEST Spectacle-Correction (ETDRS) Distance Visual Acuity	4 to 6 months	No
Secondary	Complications and Adverse Events	Number of Participants with Complications or Adverse Events	4 to 6 months	Yes