Monovision vs Multifocal Lens Insertion in Cataract Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Georgios Labiris, Democritus University of Thrace
ClinicalTrials.gov Identifier:
NCT01998698
First received: November 19, 2013
Last updated: November 29, 2013
Last verified: November 2013
  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: 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 Democritus University of Thrace:

Primary Outcome Measures:
  • VF14 score [ Time Frame: 6 months following operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distant Visual Acuity [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
  • Near Vision visual acuity [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 19, 2013
Last Updated: November 29, 2013
Health Authority: Greece: Ministry of Health and Welfare

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014