NCT01299155

Brief Summary

To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

February 17, 2011

Last Update Submit

October 22, 2012

Conditions

Cataract

Keywords

Intraocular LensPresbyopia Correcting IOL

Outcome Measures

Primary Outcomes (1)

  • Unilateral Uncorrected Near Visual Acuity

    3 months after surgery

Study Arms (2)

ReSTOR +3

EXPERIMENTAL

Bilateral implantation of a ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1

Device: ReSTOR +3

LENTIS MPlus

ACTIVE COMPARATOR

Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) Model

Device: LENTIS MPlus

Interventions

ReSTOR +3DEVICE

Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.

ReSTOR +3
LENTIS MPlusDEVICE

Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.

LENTIS MPlus

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are willing and able to understand and sign an informed consent
  • \<= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure "regular" astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements.
  • are willing and able to attend postoperative examinations per protocol schedule
  • are more than 21 years of age, of either gender and any race:
  • require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure
  • be willing to have second eye surgery within one month of first eye surgery
  • are in good ocular health, with the exception of cataracts
  • are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts
  • are able to read and understand one of the following languages: Dutch or Spanish

You may not qualify if:

  • Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery
  • An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.)
  • Previous corneal surgery and/or reshaping
  • Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy)
  • History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.)
  • History of retinal detachment
  • Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness).
  • suturing of incision required at time of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Oviedo, Principality of Asturias, 33012, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Last Updated

October 23, 2012

Record last verified: 2011-10

Locations

ES(1)