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:
Hoya Surgical Optics, Inc.
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
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292629
Contacts
| Contact: James Wartman | 909-680-3900 | james.wartman@hoya.com |
Locations
| United States, Arizona | |
| Schwartz Laser Eye Center | Recruiting |
| E. Shea Blvd, Suite C101, Arizona, United States, 85260 | |
| Contact: Katie O'Brien 4804833937 katieo@schwartzlaser.com | |
| United States, Florida | |
| Katzen Eye Care and Laser Center | Recruiting |
| Boynton Beach, Florida, United States, 33426 | |
| Contact: Margo Picard 561-732-8005 margo@katzeneyecare.com | |
| Center for Excellence in Eye Care | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Matty Infante 305-598-2020 mattyceec@bellsouth.net | |
| United States, Indiana | |
| Eye Surgeons of Indiana | Recruiting |
| Indianapolis, Indiana, United States, 46256 | |
| Contact: Brenda Wahl 317-845-9488 ext 405 brenda.wahl@esi-in.com | |
| United States, Massachusetts | |
| Eye Health Vision Centers | Recruiting |
| North Dartmouth, Massachusetts, United States, 02747 | |
| Contact: Kari Crompton 508-994-1400 kari.crompton@eyehealthvision.com | |
Sponsors and Collaborators
Hoya Surgical Optics, Inc.
Investigators
| Study Director: | James Wartman | Hoya Surgical Optics |
More Information
No publications provided
| Responsible Party: | James Wartman/ Sr. Director of Global Regulatory Affairs and QA, 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: | October 26, 2012 |
| 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:
|
Aphakia Cataract Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013