search
Back to results

Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients

Primary Purpose

Cataract, Spherical Aberrations, Intraocular Lenses

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
AMO Tecnis ZA9003
AMO Sensar AR40e
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cataract
  • Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively

Exclusion Criteria:

  • Uveitis, pathology of the retina or the optic nerve
  • Corneal scarring or irregularities
  • Astigmatism >1.5 D
  • Amblyopia
  • Perioperative complications
  • Postoperative refractive error >2.0 D of spherical equivalent
  • Postoperative DCVA <0.8 (ETDRS)

Sites / Locations

  • Dept. of Ophthalmology, Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Hypermetropic, spherical IOL

Hypermetropic, aspheric IOL

Emmetropic, spherical IOL

Emmetropic, aspheric IOL

Arm Description

AMO Sensar AR40e

AMO Tecnis ZA9003

AMO Sensar AR40e

AMO Tecnis ZA9003

Outcomes

Primary Outcome Measures

Distance-corrected intermediate visual acuity

Secondary Outcome Measures

Distance-corrected near visual acuity
Uncorrected distance visual acuity
Corrected distance visual acuity
Uncorrected near visual acuity
Corrected near visual acuity
Pseudoaccomodation
Photopic contrast sensitivity
Mesopic contrast sensitivity
Spherical aberrations
High order aberrations

Full Information

First Posted
November 21, 2013
Last Updated
June 27, 2017
Sponsor
Medical University of Graz
search

1. Study Identification

Unique Protocol Identification Number
NCT01995630
Brief Title
Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients
Official Title
Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Spherical Aberrations, Intraocular Lenses, Depth of Focus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypermetropic, spherical IOL
Arm Type
Experimental
Arm Description
AMO Sensar AR40e
Arm Title
Hypermetropic, aspheric IOL
Arm Type
Experimental
Arm Description
AMO Tecnis ZA9003
Arm Title
Emmetropic, spherical IOL
Arm Type
Active Comparator
Arm Description
AMO Sensar AR40e
Arm Title
Emmetropic, aspheric IOL
Arm Type
Active Comparator
Arm Description
AMO Tecnis ZA9003
Intervention Type
Device
Intervention Name(s)
AMO Tecnis ZA9003
Intervention Type
Device
Intervention Name(s)
AMO Sensar AR40e
Primary Outcome Measure Information:
Title
Distance-corrected intermediate visual acuity
Time Frame
3 month postop
Secondary Outcome Measure Information:
Title
Distance-corrected near visual acuity
Time Frame
3 month postop
Title
Uncorrected distance visual acuity
Time Frame
3 month postop
Title
Corrected distance visual acuity
Time Frame
3 month postop
Title
Uncorrected near visual acuity
Time Frame
3 month postop
Title
Corrected near visual acuity
Time Frame
3 month postop
Title
Pseudoaccomodation
Time Frame
3 month postop
Title
Photopic contrast sensitivity
Time Frame
3 month postop
Title
Mesopic contrast sensitivity
Time Frame
3 month postop
Title
Spherical aberrations
Time Frame
3 month postop
Title
High order aberrations
Time Frame
3 month postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cataract Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively Exclusion Criteria: Uveitis, pathology of the retina or the optic nerve Corneal scarring or irregularities Astigmatism >1.5 D Amblyopia Perioperative complications Postoperative refractive error >2.0 D of spherical equivalent Postoperative DCVA <0.8 (ETDRS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navid Ardjomand, MD
Organizational Affiliation
Dept. of Ophthalmology, Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Ophthalmology, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients

We'll reach out to this number within 24 hrs