Comperative Trial Between an Accommodative Iol and Monofocal Iol

This study is not yet open for participant recruitment.

Verified by Shaare Zedek Medical Center, January 2008

First Received: January 17, 2008 Last Updated: January 29, 2008 History of Changes

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00604305

Purpose

a comparison of two intraocular lenses in regard of accommodative power.

Condition	Intervention
CATARACT SURGERY	Device: Acrysof Device: Acuity's AIOL

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof

Resource links provided by NLM:

MedlinePlus related topics: Cataract

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

distance and near visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

centration pco [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Acrysof: Active Comparator Routine monofocal IOL	Device: Acrysof Monofocal IOL
Acuity's AIOL: Active Comparator Accomodaing IOL	Device: Acuity's AIOL Accommodating IOL

Detailed Description:

A new accomodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 30 and 65
Required cataract operation in one or both eyes
BCVA potetial at least 20/30
Clear intraoccular media
Willing to participate in study as evidenced by signing a written Informed Consent

Exclusion Criteria:Main

Prior surgery at the selected eye
No light perception or poor potential for improvement
Phacodonesis and damaged zonules
Pupil size at least 6 mm.
History of uveitis
Macular disease decreasing vision below 20/30
Amblyopia
Axial length shorter than 21 mm and longer than 25 mm

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	shaare zedek medical center ( yaacov rozenman head of eye department )
Study ID Numbers:	6666476CTIL, Rozenman-CWPMS001
Study First Received:	January 17, 2008
Last Updated:	January 29, 2008
ClinicalTrials.gov Identifier:	NCT00604305 History of Changes
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on September 10, 2009