Trial record 2 of 29 for:    Open Studies | "Lenses, Intraocular"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Navid Ardjomand, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01995630
First received: November 21, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cataract
Spherical Aberrations
Intraocular Lenses
Depth of Focus
Device: AMO Tecnis ZA9003
Device: AMO Sensar AR40e

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Distance-corrected intermediate visual acuity [ Time Frame: 3 month postop ]

Secondary Outcome Measures:
  • Distance-corrected near visual acuity [ Time Frame: 3 month postop ]
  • Uncorrected distance visual acuity [ Time Frame: 3 month postop ]
  • Corrected distance visual acuity [ Time Frame: 3 month postop ]
  • Uncorrected near visual acuity [ Time Frame: 3 month postop ]
  • Corrected near visual acuity [ Time Frame: 3 month postop ]
  • Pseudoaccomodation [ Time Frame: 3 month postop ]
  • Photopic contrast sensitivity [ Time Frame: 3 month postop ]
  • Mesopic contrast sensitivity [ Time Frame: 3 month postop ]
  • Spherical aberrations [ Time Frame: 3 month postop ]
  • High order aberrations [ Time Frame: 3 month postop ]

Estimated Enrollment: 220
Study Start Date: November 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypermetropic, spherical IOL
AMO Sensar AR40e
Device: AMO Sensar AR40e
Experimental: Hypermetropic, aspheric IOL
AMO Tecnis ZA9003
Device: AMO Tecnis ZA9003
Active Comparator: Emmetropic, spherical IOL
AMO Sensar AR40e
Device: AMO Sensar AR40e
Active Comparator: Emmetropic, aspheric IOL
AMO Tecnis ZA9003
Device: AMO Tecnis ZA9003

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT01995630

Contacts
Contact: Navid Ardjomand, MD 0043 316 385 80704 navid.ardjomand@medunigraz.at
Contact: Gernot Steinwender, MD 0043 316 385 81130 steinwender.gernot@gmx.at

Locations
Austria
Dept. of Ophthalmology, Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Navid Ardjomand, MD    0043 316 385 80704    navid.ardjomand@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Navid Ardjomand, MD Dept. of Ophthalmology, Medical University of Graz
  More Information

No publications provided

Responsible Party: Navid Ardjomand, Univ.-Doz. Dr. med. univ., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01995630     History of Changes
Other Study ID Numbers: SIOLvsAIOL
Study First Received: November 21, 2013
Last Updated: June 10, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014