Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients
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ClinicalTrials.gov Identifier: NCT01995630 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Last Update Posted : June 28, 2017
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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 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 |
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 |
- Distance-corrected intermediate visual acuity [ Time Frame: 3 month postop ]
- 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 ]

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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 |
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)

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
Austria | |
Dept. of Ophthalmology, Medical University of Graz | |
Graz, Austria, 8036 |
Principal Investigator: | Navid Ardjomand, MD | Dept. of Ophthalmology, Medical University of Graz |
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 |
Cataract Lens Diseases Eye Diseases |