Cataract
Conditions
Keywords
cataract surgery, intraocular lens
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.
Interventions
DEVICECrystalens AO
Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.
DEVICESoftPort LI61AO
Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude of Accommodation | Visit 4 (postoperative day 120-180) | The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | All visits through visit 4 (day 160-180) | Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR. |
Countries
United States
Participant flow
Recruitment details
A total of 6 subjects (11 eyes) were enrolled at one investigational site in the US. First participant enrolled 10/26/2010; last participant visit 12/01/2011.
Pre-assignment details
Due to the small sample size, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
Participants by arm
| Arm | Count |
|---|---|
| Crystalens AO A silicone multi-piece accommodating intraocular lens | 4 |
| SoftPort LI61AO A silicone multi-piece foldable aspheric intraocular lens | 2 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Crystalens AO | SoftPort LI61AO |
|---|---|---|---|
| Age, Customized Age 54 to 70 years | 6 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
Primary
Amplitude of Accommodation
The measurement of optical change in the power of the eye when viewing from far to near. Accommodation decreases as age increases resulting in an inability to focus on near objects.
Time frame: Visit 4 (postoperative day 120-180)
Population: DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.
Secondary
Visual Acuity
Number of correct letters on an early treatment diabetic retinopathy study (ETDRS) chart to measure distance visual acuity and the smallest readable print size on an Minnesota Low-Vision Reading (MNREAD) acuity chart for intermediate and near visual acuity (VA). Visual acuity measured in LogMAR.
Time frame: All visits through visit 4 (day 160-180)
Population: DUE TO THE SMALL SAMPLE SIZE, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS CAN BE MADE.