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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This study has been withdrawn prior to enrollment.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
History of Changes
  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

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 ]

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
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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013