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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Dr. Yaacov Rozenman, Shaare Zedek Medical Center
First received: January 17, 2008
Last updated: June 10, 2012
Last verified: June 2012
a comparison of two intraocular lenses in regard of accommodative power.
Device: Acuity's AIOL
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Active Comparator: Acrysof
Routine monofocal IOL
Active Comparator: Acuity's AIOL
Device: Acuity's AIOL
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.
|Ages Eligible for Study:
||30 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
- Axial length shorter than 21 mm and longer than 25 mm
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No Contacts or Locations Provided
No publications provided
ClinicalTrials.gov processed this record on November 24, 2014
||Dr. Yaacov Rozenman, Head of eye department, Shaare Zedek Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 17, 2008
||June 10, 2012
||Israel: Ministry of Health