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

NCT ID: NCT01995630

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Spherical Aberrations Intraocular Lenses Depth of Focus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hypermetropic, spherical IOL

AMO Sensar AR40e

Group Type EXPERIMENTAL

AMO Sensar AR40e

Intervention Type DEVICE

Hypermetropic, aspheric IOL

AMO Tecnis ZA9003

Group Type EXPERIMENTAL

AMO Tecnis ZA9003

Intervention Type DEVICE

Emmetropic, spherical IOL

AMO Sensar AR40e

Group Type ACTIVE_COMPARATOR

AMO Sensar AR40e

Intervention Type DEVICE

Emmetropic, aspheric IOL

AMO Tecnis ZA9003

Group Type ACTIVE_COMPARATOR

AMO Tecnis ZA9003

Intervention Type DEVICE

Interventions

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AMO Tecnis ZA9003

Intervention Type DEVICE

AMO Sensar AR40e

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Navid Ardjomand

Univ.-Doz. Dr. med. univ.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Navid Ardjomand, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Ophthalmology, Medical University of Graz

Locations

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Dept. of Ophthalmology, Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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SIOLvsAIOL

Identifier Type: -

Identifier Source: org_study_id

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