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.
1 other identifier
interventional
125
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2011
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
March 20, 2015
CompletedMarch 20, 2015
March 1, 2015
1.2 years
February 4, 2011
February 11, 2015
March 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Acuity
BEST Spectacle-Correction (ETDRS) Distance Visual Acuity
4 to 6 months
Secondary Outcomes (1)
Complications and Adverse Events
4 to 6 months
Study Arms (1)
Investigational intraocular lens
EXPERIMENTALiSert 251 intraocular lens
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Schwartz Laser Eye Center
E. Shea Blvd, Suite C101, Arizona, 85260, United States
Katzen Eye Care and Laser Center
Boynton Beach, Florida, 33426, United States
Center for Excellence in Eye Care
Miami, Florida, 33176, United States
Eye Surgeons of Indiana
Indianapolis, Indiana, 46256, United States
Eye Health Vision Centers
North Dartmouth, Massachusetts, 02747, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kees den Besten, Vice President Global Quality, Regulatory Affairs, and Clinical Research
- Organization
- Hoya Surgical Optics, Inc.
Study Officials
- STUDY DIRECTOR
Kees den Besten
Hoya Surgical Optics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2011
First Posted
February 9, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 20, 2015
Results First Posted
March 20, 2015
Record last verified: 2015-03