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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Hoya Surgical Optics, Inc..
Recruitment status was  Active, not recruiting
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

February 21, 2012
August 10, 2012
February 2012
August 2012   (final data collection date for primary outcome measure)
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544777 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study
Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aphakia
  • Cataract
  • Device: Study IOL
    Aspheric IOL for correction of aphakia
    Other Name: Hoya iSert 751 IOL
  • Device: Hoya iSert 751
    Model 751 in one eye, standard IOL in other eye
    Other Name: Hoya iSert Model 751
  • Device: Negatively aspheric IOL
    Negatively aspheric IOL in both eyes
    Other Name: Hoya iSert model 251 or equivalent
  • Experimental: Both Eyes
    Model 751 IOL implanted in both eyes.
    Intervention: Device: Study IOL
  • Experimental: Single eye
    Model 751 IOL in one eye
    Intervention: Device: Hoya iSert 751
  • Active Comparator: Control
    Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent
    Intervention: Device: Negatively aspheric IOL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01544777
DOF-1
No
Hoya Surgical Optics, Inc.
Hoya Surgical Optics, Inc.
Not Provided
Principal Investigator: Graham Barrett, MD Sir Charles Gairdner Hospital, Nedlans WA
Hoya Surgical Optics, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP