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

NCT01292629 — Not applicable, Completed, 125 participants, Hoya Surgical Optics, Inc.

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

Registry	NCT01292629
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	125 (Actual)
Sponsor	Hoya Surgical Optics, Inc. (Industry)
Conditions	Aphakia, Cataract
Interventions	iSert 251 intraocular lens (Device)
Dates	start 2011-02-01, primary completion 2012-05-01, completion 2012-05-01, first posted 2011-02-09, last updated 2026-10-02
Locations	5 sites in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Investigational intraocular lens	Experimental	Device: iSert 251 intraocular lens	iSert 251 intraocular lens

iSert 251 intraocular lens (Device): aphakic intraocular lens

+Outcome measures

Primary outcomes

Visual Acuity [4 to 6 months]: BEST Spectacle-Correction (ETDRS) Distance Visual Acuity

Secondary outcomes

Complications and Adverse Events [4 to 6 months]: Number of Participants with Complications or Adverse Events

+Eligibility

Sex: All, ages: 50 Years to any

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.

+Posted results

Participant flow

Milestone	iSert 251: iSert 251 Intraocular Lens
Started	125
Completed	125
Not completed	0

Outcome results

Visual Acuity (Primary), Number, subjects: iSert 251: iSert 251 Intraocular Lens 121
Complications and Adverse Events (Secondary), Number, participants: iSert 251 Aphakik IOL 0

Adverse events

Time frame: 4-6 months

Arm	Deaths	Serious adverse events	Other adverse events
iSert 251: iSert 251 Intraocular Lens	0	0/125 (0.0%)	0/125 (0.0%)

+Locations (5)

Facility	City	Country
Schwartz Laser Eye Center	Scottsdale, Arizona	United States
Katzen Eye Care and Laser Center	Boynton Beach, Florida	United States
Center for Excellence in Eye Care	Miami, Florida	United States
Eye Surgeons of Indiana	Indianapolis, Indiana	United States
Eye Health Vision Centers	North Dartmouth, Massachusetts	United States

+Investigators

Kees den Besten, Study director, Hoya Surgical Optics