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

Not Applicable

Completed

• Conditions: Cataract; Aphakia
• Interventions: Device: iSert 251 intraocular lens

• Registration Number: NCT01292629
• Lead Sponsor: Hoya Surgical Optics, Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-04
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-09
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2015-02-11
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Results First Posted: 2015-03-20
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational intraocular lens	iSert 251 intraocular lens	iSert 251 intraocular lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	4 to 6 months	BEST Spectacle-Correction (ETDRS) Distance Visual Acuity

Secondary Outcome Measures

Name	Time	Method
Complications and Adverse Events	4 to 6 months	Number of Participants with Complications or Adverse Events

Trial Locations

Locations (5)

Katzen Eye Care and Laser Center; 🇺🇸 Boynton Beach, Florida, United States

Eye Health Vision Centers; 🇺🇸 North Dartmouth, Massachusetts, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Eye Surgeons of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Schwartz Laser Eye Center; 🇺🇸 E. Shea Blvd, Suite C101, Arizona, United States