Clinical Evaluation of a New Aspheric Intraocular Lens.

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786565
• Other study ID #: 001/04
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2008
• Last updated: December 7, 2011
• Start date: January 2004
• Est. completion date: January 2008

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Advanced Akreos Adapt in one operated eye.
Cataract surgery to implant the assigned IOL according to randomized schedule.
• Akreos Adapt in fellow operated eye.
Cataract surgery to implant the assigned IOL according to randomized schedule.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Low Contrast Uncorrected Visual Acuity Following Cataract Surgery	Low contrast uncorrected visual acuity 3 months post cataract surgery	3 months	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	High Contrast Visual Acuity Uncorrected		3 months	No
Secondary	High Contrast Visual Acuity Best Corrected		3 months	No
Secondary	High Contrast Visual Acuity		12 months	No
Secondary	High Contrast Visual Acuity Uncorrected		24 Months	No
Secondary	High Contrast Visual Acuity Best Corrected		24 Months	No
Secondary	Low Contrast Visual Acuity	Uncorrected Low contrast visual acuity - LogMar visual acuity value	1 month	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No