Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comperative Trial Between an Accommodative Iol and Monofocal Iol

This study has been withdrawn prior to enrollment.
(Company could not supply the accommodating intraocular lenses for the study)
Sponsor:
Information provided by (Responsible Party):
Dr. Yaacov Rozenman, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00604305
First received: January 17, 2008
Last updated: June 10, 2012
Last verified: June 2012
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof

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 ]

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acrysof
Routine monofocal IOL
Device: Acrysof
Monofocal IOL
Active Comparator: Acuity's AIOL
Accomodaing IOL
Device: Acuity's AIOL
Accommodating IOL

Detailed Description:

A new accommodating 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Yaacov Rozenman, Head of eye department, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00604305     History of Changes
Other Study ID Numbers: 6666476CTIL, Rozenman-CWPMS001
Study First Received: January 17, 2008
Last Updated: June 10, 2012
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 20, 2014