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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00604305
Other study ID # 6666476CTIL
Secondary ID Rozenman-CWPMS00
Status Withdrawn
Phase N/A
First received January 17, 2008
Last updated June 10, 2012
Start date March 2008
Est. completion date December 2012

Study information

Verified date June 2012
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Acrysof
Monofocal IOL
Acuity's AIOL
Accommodating IOL

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shaare Zedek Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary distance and near visual acuity 1 year Yes
Secondary centration pco 1 year Yes
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