Comperative Trial Between an Accommodative Iol and Monofocal Iol

CATARACT SURGERY Clinical Trial

Official title:

A Randomized Single Blind Comparative Study of the Acuity's C-Well Accommodating Intra Occular Lens (AIOL) Against Alcon's Acrysof

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

• CATARACT SURGERY

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