Clinical Evaluation of a New Aspheric Intraocular Lens.

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Advanced Akreos Adapt in one operated eye.; Device: Akreos Adapt in fellow operated eye.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced Akreos Adapt; Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).	Device: Advanced Akreos Adapt in one operated eye.; Cataract surgery to implant the assigned IOL according to randomized schedule.
Experimental: Akreos Adapt; Akreos Adapt Spherical Intraocular Lens (IOL).	Device: Akreos Adapt in fellow operated eye.; Cataract surgery to implant the assigned IOL according to randomized schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Contrast Best Corrected Visual Acuity Following Cataract Surgery	Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.	3 months
Low Contrast Uncorrected Visual Acuity Following Cataract Surgery	Low contrast uncorrected visual acuity 3 months post cataract surgery	3 months
Photopic Contrast Sensitivity	The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)	3 months
Mesoptic Contrast Sensitivity	The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)	3 Months
Posterior Capsule Opacification Score	Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Contrast Visual Acuity	High contrast visual acuity (ability to distinguish objects of contrasting color such as black on white) uncorrected and best corrected visual acuity.	1 month
High Contrast Visual Acuity Uncorrected		3 months
High Contrast Visual Acuity Best Corrected		3 months
High Contrast Visual Acuity		12 months
High Contrast Visual Acuity Uncorrected		24 Months
High Contrast Visual Acuity Best Corrected		24 Months
Low Contrast Visual Acuity	Uncorrected Low contrast visual acuity - LogMar visual acuity value	1 month
Contrast Sensitivity Photopic 1.5cpd	The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)	1 month
Contrast Sensitivity Photopic	The mean photopic (day light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)	1 month
Contrast Sensitivity Mesoptic 1.5 Cpd	The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)	1 month
Contrast Sensitivity Mesoptic	The mean mesopic (dim light) contrast sensitivity were to be compared between both IOLs for each special frequency (1.5, 3.0, 6.0, 12.0 and 18 cpd)	1 month
Posterior Capsule Opacification	Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.	12 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: November 3, 2008
• First Submitted That Met QC Criteria: November 5, 2008
• First Posted (Estimate): November 6, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 001/04