NCT01998698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2013

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

November 19, 2013

Last Update Submit

January 14, 2017

Conditions

Cataract

Keywords

cataractphacoemulsificationmonovisionmultifocal lens

Outcome Measures

Primary Outcomes (1)

  • VF14 score

    6 months following operation

Secondary Outcomes (2)

  • Distant Visual Acuity

    6 months following surgery

  • Near Vision visual acuity

    6 months following surgery

Study Arms (2)

Monovision Group

ACTIVE COMPARATOR

Phacoemulsification surgery with intraocular lens implantation (monovision correction)

Procedure: Phacoemulsification surgery

Multifocal Group

ACTIVE COMPARATOR

Phacoemulsification surgery with intraocular lens implantation (multifocal lens insertion)

Procedure: Phacoemulsification surgery

Interventions

Phacoemulsification surgeryPROCEDURE

Phacoemulsification surgery with intraocular lens implantation and monovision correction

Also known as: Alcon Infiniti Vision System platform, Visthesia, Carl Zeiss, Germany, Alcon Intraocular lens SN60WF
Monovision Group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral senile cataract

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

  • 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.

    PMID: 24962144RESULT

MeSH Terms

Conditions

Cataract

Interventions

visthesia

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Georgios Labiris, MD, PhD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2013

First Posted

December 2, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

GR(1)