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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995630
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Navid Ardjomand, Medical University of Graz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Spherical Aberrations Intraocular Lenses Depth of Focus Device: AMO Tecnis ZA9003 Device: AMO Sensar AR40e Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients: A Randomized Clinical Trial
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 26, 2016
Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Distance-corrected near visual acuity [ Time Frame: 3 month postop ]
  2. Uncorrected distance visual acuity [ Time Frame: 3 month postop ]
  3. Corrected distance visual acuity [ Time Frame: 3 month postop ]
  4. Uncorrected near visual acuity [ Time Frame: 3 month postop ]
  5. Corrected near visual acuity [ Time Frame: 3 month postop ]
  6. Pseudoaccomodation [ Time Frame: 3 month postop ]
  7. Photopic contrast sensitivity [ Time Frame: 3 month postop ]
  8. Mesopic contrast sensitivity [ Time Frame: 3 month postop ]
  9. Spherical aberrations [ Time Frame: 3 month postop ]
  10. High order aberrations [ Time Frame: 3 month postop ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995630


Locations
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Austria
Dept. of Ophthalmology, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Navid Ardjomand, MD Dept. of Ophthalmology, Medical University of Graz
More Information
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Responsible Party: Navid Ardjomand, Univ.-Doz. Dr. med. univ., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01995630    
Other Study ID Numbers: SIOLvsAIOL
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases