Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00786565

Purpose

This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.

Condition	Intervention	Phase
Cataract	Device: Akreos Adapt in first operated eye / Advanced Akreos Adapt Device: Akreos Adapt in second operated eye / Advanced Akreos Adapt in first operated eye	Phase IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Parallel Assignment

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Visual performance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Posterior Capsular Opacification [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	January 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Akreos Adapt in first operated eye / Advanced Akreos Adapt in second operated eye.	Device: Akreos Adapt in first operated eye / Advanced Akreos Adapt Cataract surgery to implant the assigned IOL according to randomized schedule.
2 Akreos Adapt in second operated eye / Advanced Akreos Adapt in first operated eye	Device: Akreos Adapt in second operated eye / Advanced Akreos Adapt in first operated eye Cataract surgery to implant the assigned IOL according to randomized schedule.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.

Exclusion Criteria:

Patients with corneal damage.
Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
Patients with any ocular pathology, other than the cataract, having repercussions on visual function:

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Bausch & Lomb Chauvin-Opsia S.A.S. ( Anne Williart )
Study ID Numbers:	001/04
Study First Received:	November 3, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786565
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 16, 2009