Clinical trial NCT01225952: Three Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision 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: phacoemulsification
intraocular lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 93
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 compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.


Eligibility criteria: Inclusion Criteria:

* Subjects must be undergoing primary IOL implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 diopters (D) to 33.00 D.
* Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes.
* Subjects must have stopped contact lens wear for at least two weeks for soft lens wearers or three weeks for gas permeable lens wearers prior to biometry and surgery.
* At the time of surgery, subjects must have an intact centered capsulorhexis, intact posterior capsule, and no zonular rupture.
* Subjects must have ≤ 1.25 D of preoperative corneal astigmatism in both eyes.

Exclusion Criteria:

* Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level of 20/32 or worse.
* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome.
* 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 uncontrolled glaucoma.
* Subjects with previous retinal detachment.
* Subjects with visually significant diabetic retinopathy (proliferative or nonproliferative) which reduces potential acuity to 20/32 or worse.
* Subjects with rubella, bilateral congenital, traumatic, complicated or polar cataract.
* Subjects with marked microphthalmos or aniridia.
* Subjects who have had previous corneal surgery.
* Subjects with irregular corneal astigmatism.
* Subjects with amblyopia which reduces potential acuity to 20/32 or worse.
* Subjects with optic atrophy.
* Subjects with iris neovascularization.
* Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/32 or worse.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.

Primary outcomes:
measure: Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
Secondary outcomes:
measure: Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
timeFrame: Postoperative visit 3 (day 30-60)
measure: Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
measure: Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree)
timeFrame: Postoperative visit 4 (day 120-180)
Other outcomes:
Locations:
city: Makati City
country: Philippines
facility: Asian Eye Institute
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Tes Ignacio, MD
role: STUDY_DIRECTOR
References: