Skip to main content
OpenTrials
Completed

NCT Number: NCT01292629

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

The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iSert 251 intraocular lens

Device

aphakic intraocular lens

Primary outcomes

  1. Visual Acuity

    Time frame: 4 to 6 months

    BEST Spectacle-Correction (ETDRS) Distance Visual Acuity

Secondary outcomes

  1. Complications and Adverse Events

    Time frame: 4 to 6 months

    Number of Participants with Complications or Adverse Events

Sponsors and collaborators

Lead sponsor

Hoya Surgical Optics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 9, 2011
Registry last updated
Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.