Clinical trial NCT01241279: Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Official title: A Two Arm Prospective, Randomized, Double-Masked Clinical Evaluation of Accommodation Measurements After Bilateral Implantation of an Aspheric Accommodating Lens and Monofocal Aspheric Lenses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract
Keywords: cataract surgery
intraocular lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 6
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 demonstrate the correlation of near vision and changes in higher order aberrations following lens extraction and to characterize the defocus curves of Crystalens® AO™ intraocular lens (IOL) versus the monofocal aspheric SofPort® LI61AO IOL in adults.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear intraocular media other than cataract.
* 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 be undergoing primary IOL implantation for the correction of aphakia following central continuous curvilinear anterior capsulorrhexis and phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 D to 30.00 D.
* Subjects must be willing and able to return for all scheduled follow-up examinations for each eye from days 1 through 180 following surgery.
* Subjects must have ≤ 1.25 D of preoperative corneal astigmatism.

Exclusion Criteria:

* Subjects with corneal pathology potentially affecting topography.
* Subjects whose fundus cannot be assessed preoperatively.
* Subjects with diagnoses of degenerative visual disorders (eg, macular degeneration, or other retinal disorders) that cause potential acuity losses to a level worse than 20/30 as verified by OCT.
* 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 non-proliferative) which reduces potential acuity to 20/30 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 worse than 20/30.
* Subjects with optic atrophy.
* Subjects with iris neovascularization.
* Subjects with clinically significant retinal pigment epithelium/macular changes which reduces potential acuity to 20/30 or worse.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
* Subjects lacking intact binocular vision.

Primary outcomes:
measure: Amplitude of Accommodation
timeFrame: Visit 4 (postoperative day 120-180)
Secondary outcomes:
measure: Visual Acuity
timeFrame: All visits through visit 4 (day 160-180)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Bausch & Lomb
state: California
Study officials:
affiliation: Valeant Pharmaceuticals/Bausch & Lomb Incorporated
name: Johnson Varughese
role: STUDY_DIRECTOR
References: