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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014