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Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study (751)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01544777
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.

Condition or disease Intervention/treatment
Aphakia Cataract Device: Study IOL Device: Hoya iSert 751 Device: Negatively aspheric IOL

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
Study Start Date : February 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Both Eyes
Model 751 IOL implanted in both eyes.
Device: Study IOL
Aspheric IOL for correction of aphakia
Other Name: Hoya iSert 751 IOL
Experimental: Single eye
Model 751 IOL in one eye
Device: Hoya iSert 751
Model 751 in one eye, standard IOL in other eye
Other Name: Hoya iSert Model 751
Active Comparator: Control
Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent
Device: Negatively aspheric IOL
Negatively aspheric IOL in both eyes
Other Name: Hoya iSert model 251 or equivalent


Outcome Measures

Primary Outcome Measures :
  1. Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near [ Time Frame: Up to 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Senile cataract
  • Patient identified as a candidate for cataract surgery and IOL implantation
  • Willing to sign informed consent document approved by the Ethical Committee
  • Willing to complete all required tests and exams per this protocol

Exclusion Criteria:

  • Amblyopia
  • History or evidence of any ocular disease that may affect visual acuity
  • Previous ocular surgery, including refraction surgery
  • Ocular anomalies (e.g. microphthalmos, kerataconous)
  • Subjects with greater than 1.0 D of corneal astigmatism
  • Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544777


Locations
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Hoya Surgical Optics, Inc.
Investigators
Principal Investigator: Graham Barrett, MD Sir Charles Gairdner Hospital, Nedlans WA
More Information

Responsible Party: Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier: NCT01544777     History of Changes
Other Study ID Numbers: DOF-1
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: August 2012

Keywords provided by Hoya Surgical Optics, Inc.:
Aphakia
Cataract

Additional relevant MeSH terms:
Cataract
Aphakia
Lens Diseases
Eye Diseases