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Comperative Trial Between an Accommodative Iol and Monofocal Iol

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ClinicalTrials.gov Identifier: NCT00604305
Recruitment Status : Withdrawn (Company could not supply the accommodating intraocular lenses for the study)
First Posted : January 30, 2008
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Yaacov Rozenman, Shaare Zedek Medical Center

Brief Summary:
a comparison of two intraocular lenses in regard of accommodative power.

Condition or disease Intervention/treatment Phase
CATARACT SURGERY Device: Acrysof Device: Acuity's AIOL Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Acrysof
Routine monofocal IOL
Device: Acrysof
Monofocal IOL

Active Comparator: Acuity's AIOL
Accomodaing IOL
Device: Acuity's AIOL
Accommodating IOL




Primary Outcome Measures :
  1. distance and near visual acuity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. centration pco [ Time Frame: 1 year ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases