NCT00349583

Brief Summary

The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
Last Updated

June 1, 2007

Status Verified

May 1, 2007

First QC Date

July 5, 2006

Last Update Submit

May 30, 2007

Conditions

CataractDry Eye

Interventions

Topical Cyclosporine, TearsDRUG

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • · Males or females \> 50 years old
  • Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
  • Likely to complete all study visits and able to provide informed consent
  • Visual potential of 20/25 or better

You may not qualify if:

  • · Prior use of topical cyclosporine
  • Known contraindications to any study medication or ingredients
  • Active ocular diseases or uncontrolled systemic disease
  • Active ocular allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

MeSH Terms

Conditions

CataractDry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesLacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Eric Donnenfeld, MD

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 7, 2006

Last Updated

June 1, 2007

Record last verified: 2007-05

Locations

US(1)