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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01544777
First received: February 21, 2012
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Aphakia
Cataract
 Device: Study IOL
Device: Hoya iSert 751
Device: Negatively aspheric IOL
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Hoya Surgical Optics, Inc.:

Primary Outcome Measures:
  • Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hoya Surgical Optics, Inc.
ClinicalTrials.gov Identifier: NCT01544777     History of Changes
Other Study ID Numbers: DOF-1
Study First Received: February 21, 2012
Last Updated: August 10, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Aphakia
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013