Clinical Evaluation of a New Aspheric Intraocular Lens.

Phase 4

Completed

• Conditions: Cataract
• Interventions: Device: Akreos Adapt in fellow operated eye.; Device: Advanced Akreos Adapt in one operated eye.

• Registration Number: NCT00786565
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Results First Submitted: 2009-02-20
• Results First Submitted QC: 2010-12-09
• Results First Posted: 2011-01-05
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Akreos Adapt	Akreos Adapt in fellow operated eye.	Akreos Adapt Spherical Intraocular Lens (IOL).
Advanced Akreos Adapt	Advanced Akreos Adapt in one operated eye.	Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).

Primary Outcome Measures

Name	Time	Method
Low Contrast Best Corrected Visual Acuity Following Cataract Surgery	3 months	Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.
Low Contrast Uncorrected Visual Acuity Following Cataract Surgery	3 months	Low contrast uncorrected visual acuity 3 months post cataract surgery
Photopic Contrast Sensitivity	3 months	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)
Mesoptic Contrast Sensitivity	3 Months	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)
Posterior Capsule Opacification Score	24 months	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.

Secondary Outcome Measures

Name	Time	Method
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	1 month	Uncorrected Low contrast visual acuity - LogMar visual acuity value
Contrast Sensitivity Photopic 1.5cpd	1 month	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)
Contrast Sensitivity Photopic	1 month	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)
Contrast Sensitivity Mesoptic 1.5 Cpd	1 month	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)
Contrast Sensitivity Mesoptic	1 month	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)
Posterior Capsule Opacification	12 months	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.