The goals of this feasibility study are to learn more about the performance of the intraocular lens (IOL), if the IOL is safe for use, and what the best surgical techniques are for implanting the IOL in patients who require correction of aphakia following phacoemulsification extraction of a senile cataract.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
This lens is accommodating.
Monofocal lens
Rates of cumulative and persistent surgical related complications observed in the Adaptilens A-IOL implanted eyes, compared to threshold rates when adjusted for the type of pre-existing condition for which the subjects are being treated.
Cumulative rates of cystoid macular edema, hypopyon, endophthalmitis, lens dislocated from posterior chamber, pupillary block, retinal detachment, secondary surgical intervention. Persistent rates of cornela edema at 3 months postop or later, cystoid macular edema, iritis, IOP \>30 mm Hg requiring treatment.
Time frame: From enrollment to the end of the study at 36 months.
Effectiveness parameter corrected distance visual acuity (CDVA) throughout the course of the study.
Effectiveness parameter to be evaluated is improvement in corrected distance visual acuity (CDVA).
Time frame: Enrollment through end of the study at 36 months.
Change in uncorrected near visual acuity (UNVA) throughout the study.
Improvement in uncorrected near visual acuity (UNVA) will be evaluated as a secondary measure of visual performance.
Time frame: Enrollment through the end of the trial at 36 months.
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