search
Back to results

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

Primary Purpose

Aphakia, Cataract

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Study IOL
Hoya iSert 751
Negatively aspheric IOL
Sponsored by
Hoya Surgical Optics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring Aphakia, Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sir Charles Gairdner Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Both Eyes

Single eye

Control

Arm Description

Model 751 IOL implanted in both eyes.

Model 751 IOL in one eye

Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent

Outcomes

Primary Outcome Measures

Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near

Secondary Outcome Measures

Full Information

First Posted
February 21, 2012
Last Updated
March 23, 2015
Sponsor
Hoya Surgical Optics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01544777
Brief Title
Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study
Acronym
751
Official Title
Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoya Surgical Optics, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
Aphakia, Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Both Eyes
Arm Type
Experimental
Arm Description
Model 751 IOL implanted in both eyes.
Arm Title
Single eye
Arm Type
Experimental
Arm Description
Model 751 IOL in one eye
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Aphakia treatment by negatively aspheric IOL implant, Hoya iSert model 251 or equivalent
Intervention Type
Device
Intervention Name(s)
Study IOL
Other Intervention Name(s)
Hoya iSert 751 IOL
Intervention Description
Aspheric IOL for correction of aphakia
Intervention Type
Device
Intervention Name(s)
Hoya iSert 751
Other Intervention Name(s)
Hoya iSert Model 751
Intervention Description
Model 751 in one eye, standard IOL in other eye
Intervention Type
Device
Intervention Name(s)
Negatively aspheric IOL
Other Intervention Name(s)
Hoya iSert model 251 or equivalent
Intervention Description
Negatively aspheric IOL in both eyes
Primary Outcome Measure Information:
Title
Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham Barrett, MD
Organizational Affiliation
Sir Charles Gairdner Hospital, Nedlans WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs