search
Back to results

Monovision vs Multifocal Lens Insertion in Cataract Patients

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Phacoemulsification surgery
Phacoemulsification surgery
Sponsored by
Democritus University of Thrace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring cataract, phacoemulsification, monovision, multifocal lens

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Bilateral senile cataract

Exclusion Criteria:

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

Sites / Locations

  • University Hospital of Alexandroupolis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Monovision Group

Multifocal Group

Arm Description

Phacoemulsification surgery with intraocular lens implantation (monovision correction)

Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion)

Outcomes

Primary Outcome Measures

VF14 score

Secondary Outcome Measures

Distant Visual Acuity
Near Vision visual acuity

Full Information

First Posted
November 19, 2013
Last Updated
January 14, 2017
Sponsor
Democritus University of Thrace
search

1. Study Identification

Unique Protocol Identification Number
NCT01998698
Brief Title
Monovision vs Multifocal Lens Insertion in Cataract Patients
Official Title
Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Democritus University of Thrace

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, phacoemulsification, monovision, multifocal lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monovision Group
Arm Type
Active Comparator
Arm Description
Phacoemulsification surgery with intraocular lens implantation (monovision correction)
Arm Title
Multifocal Group
Arm Type
Active Comparator
Arm Description
Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion)
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification surgery
Other Intervention Name(s)
Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Alcon Intraocular lens SN60WF
Intervention Description
Phacoemulsification surgery with intraocular lens implantation and monovision correction
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification surgery
Other Intervention Name(s)
Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Hoya Intraocular lens PY-60MV
Intervention Description
Phacoemulsification surgery with multifocal intraocular lens implantation
Primary Outcome Measure Information:
Title
VF14 score
Time Frame
6 months following operation
Secondary Outcome Measure Information:
Title
Distant Visual Acuity
Time Frame
6 months following surgery
Title
Near Vision visual acuity
Time Frame
6 months following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Labiris, MD, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Alexandroupolis
City
Alexandroupolis
State/Province
Evros
ZIP/Postal Code
68100
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
24962144
Citation
Labiris G, Giarmoukakis A, Patsiamanidi M, Papadopoulos Z, Kozobolis VP. Mini-monovision versus multifocal intraocular lens implantation. J Cataract Refract Surg. 2015 Jan;41(1):53-7. doi: 10.1016/j.jcrs.2014.06.015. Epub 2014 Jun 21.
Results Reference
result

Learn more about this trial

Monovision vs Multifocal Lens Insertion in Cataract Patients

We'll reach out to this number within 24 hrs