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Monovision vs Multifocal Lens Insertion in Cataract Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01998698
First Posted: December 2, 2013
Last Update Posted: January 18, 2017
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.
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace
  Purpose
The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.

Condition Intervention
Cataract Procedure: Phacoemulsification surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Georgios Labiris, Democritus University of Thrace:

Primary Outcome Measures:
  • VF14 score [ Time Frame: 6 months following operation ]

Secondary Outcome Measures:
  • Distant Visual Acuity [ Time Frame: 6 months following surgery ]
  • Near Vision visual acuity [ Time Frame: 6 months following surgery ]

Enrollment: 60
Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Multifocal Group
Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral senile cataract

Exclusion Criteria:

  • Glaucoma
  • Corneal pathology
  • Fundus pathology
  • Severe neurological/mental diseases that interfere with visual acuity
  • Former intraocular operation
  Contacts and Locations
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): NCT01998698


Locations
Greece
University Hospital of Alexandroupolis
Alexandroupolis, Evros, Greece, 68100
Sponsors and Collaborators
Democritus University of Thrace
Investigators
Principal Investigator: Georgios Labiris, MD, PhD Assistant Professor
  More Information

Publications:
Responsible Party: Georgios Labiris, Assistant Professor, Democritus University of Thrace
ClinicalTrials.gov Identifier: NCT01998698     History of Changes
Other Study ID Numbers: 192/19-11-2013
First Submitted: November 19, 2013
First Posted: December 2, 2013
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Georgios Labiris, Democritus University of Thrace:
cataract
phacoemulsification
monovision
multifocal lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases