Clinical trial NCT01122576: Evaluation of 3 Intraocular Lenses Following Lens Extraction
Official title: A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Intra Ocular Lens
Ocular surgery
Phacoemulsification
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 D to 33.00 D
* Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion Criteria:

* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
* Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
* Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.

Primary outcomes:
measure: Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
timeFrame: Postoperative visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
timeFrame: Postoperative visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
timeFrame: Postoperative visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
timeFrame: Postoperative visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
timeFrame: Postoperative visit 4 ( 4-6 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
timeFrame: Postoperative visit 4 ( 4-6 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
timeFrame: Postoperative visit 4 ( 4-6 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
timeFrame: Postoperative visit 4 ( 4-6 months)
measure: Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
timeFrame: Postoperative visit 4 ( 4-6 months)
Secondary outcomes:
measure: Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
timeFrame: Visit 3 (2-3 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree
timeFrame: Visit 4 (4-6 months)
measure: Optical Scatter
timeFrame: Visit 3 (2-3 months)
measure: Optical Scatter
timeFrame: Visit 4 (4-6 months)
measure: Monocular Halo and Starburst
timeFrame: Visit 3 (2-3 months)
measure: Monocular Halo and Starburst
timeFrame: Visit 4 (4-6 months)
measure: Binocular Halo and Starburst
timeFrame: Visit 3 (2-3 months)
measure: Binocular Halo and Starburst
timeFrame: Visit 4 (4-6 months)
measure: Manifest Refraction
timeFrame: Visit 3 (2-3 Months)
measure: Manifest Refraction
timeFrame: Visit 4 (4-6 Months)
measure: Uncorrected Distance Visual Acuity
timeFrame: Visit 3 (2-3 months) Visit 4 (4-6 months)
measure: Best-corrected Distance Visual Acuity
timeFrame: Visit 3 (2-3 months) Visit 4 (4-6 months)
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: Bausch & Lomb, Inc
state: California
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Omid Khodai, OD, RAC
role: STUDY_DIRECTOR
References: