Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses

July 17, 2017 updated by: Michael Lasta, Hospital Hietzing

Effect of Spherical Aberration on the Optical Quality After Implantation of Two Different Aspherical Intraocular Lenses

Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women between 50 and 85 years with age related cataract

Description

Inclusion Criteria:

  • Bilateral age-related cataract
  • Potential postoperative visual acuity of 1.0 Snellen
  • No relevant ocular pathology other than cataract
  • Written informed consent to surgery and participation in the study

Exclusion Criteria:

  • Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
  • Optical media disturbances due to: corneal and vitreal opacity, PEX
  • Preceding ocular trauma or ocular surgery within 6 months
  • Inability to cooperate
  • Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2 different Intraocular lenses
2 different intraocular lenses were compared
Device: intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modulation transfer function (MTF) at 3 months after surgery
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Hietzing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (ACTUAL)

July 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-12-256-0113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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