Monovision vs Multifocal Lens Insertion in Cataract Patients

January 14, 2017 updated by: Georgios Labiris, Democritus University of Thrace

Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery

The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • University Hospital of Alexandroupolis

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

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral senile cataract

Exclusion Criteria:

  • Glaucoma
  • Corneal pathology
  • Fundus pathology
  • Severe neurological/mental diseases that interfere with visual acuity
  • Former intraocular operation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Monovision Group
Phacoemulsification surgery with intraocular lens implantation (monovision correction)
Procedure: Phacoemulsification surgery
Phacoemulsification surgery with intraocular lens implantation and monovision correction
Other Names:
  • Alcon Infiniti Vision System platform
  • Visthesia, Carl Zeiss, Germany
  • Alcon Intraocular lens SN60WF
Procedure: Phacoemulsification surgery
Phacoemulsification surgery with multifocal intraocular lens implantation
Other Names:
  • Alcon Infiniti Vision System platform
  • Visthesia, Carl Zeiss, Germany
  • Hoya Intraocular lens PY-60MV
Active Comparator: Multifocal Group
Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion)
Procedure: Phacoemulsification surgery
Phacoemulsification surgery with intraocular lens implantation and monovision correction
Other Names:
  • Alcon Infiniti Vision System platform
  • Visthesia, Carl Zeiss, Germany
  • Alcon Intraocular lens SN60WF
Procedure: Phacoemulsification surgery
Phacoemulsification surgery with multifocal intraocular lens implantation
Other Names:
  • Alcon Infiniti Vision System platform
  • Visthesia, Carl Zeiss, Germany
  • Hoya Intraocular lens PY-60MV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VF14 score
Time Frame: 6 months following operation
6 months following operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Distant Visual Acuity
Time Frame: 6 months following surgery
6 months following surgery
Near Vision visual acuity
Time Frame: 6 months following surgery
6 months following surgery

Collaborators and Investigators

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

Sponsor

Democritus University of Thrace

Investigators

  • Principal Investigator: Georgios Labiris, MD, PhD, Assistant Professor

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

March 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 29, 2013

First Posted (Estimate)

December 2, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192/19-11-2013

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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