A study to learn how well an artificial lens, called an intraocular lens (IOL), works in adults who have cataract surgery. During this type of surgery, the eye's natural lens is removed and replaced with an artificial lens to help restore vision. The main goal of the study is to evaluate vision after the lens is placed in the eye. About one year after surgery, participants' vision will be measured to understand how clearly they can see. The study will also look at how the lens performs over time, including how well it remains in place in the eye. The results of this study will help provide more information about how this lens performs in adults undergoing cataract surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Injector and one-piece (1P) monofocal IOL
Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5
A binary outcome of achieving best-corrected distance visual acuity (BCDVA) of 0.30 logarithm of the minimum angle of resolution (logMAR) or better, or not, at postoperative days 330-390 (Form 5) BCDVA will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) illuminated charts
Time frame: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
Proportion of Participants with Incidence of Selected Ocular Adverse Events
This safety outcome measure evaluates whether participants experience any of the following ocular adverse events after treatment, recorded as a binary outcome (occurrence: yes/no). Cumulative adverse events assessed include Cystoid macular edema, Hypopyon, Endophthalmitis, lens dislocation from the posterior chamber, Pupillary block, Retinal detachment, and secondary surgical interventions (excluding posterior capsulotomies). In addition, persistent adverse events are assessed as present or absent, including corneal stroma edema, persistent Cystoid macular edema, Iritis, and elevated intraocular pressure requiring treatment.
Time frame: Baseline through end of study (up to 15 months)
Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4
Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit (Form 4) remains within predefined thresholds.
Time frame: Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180
Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 5
Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit (Form 5) remains within predefined thresholds.
Time frame: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 4
Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit 4 (Form 4) remains within predefined thresholds.
Time frame: Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180
Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 5
Evaluation of the rotational stability of the implanted monofocal IOL by assessing changes in lens axis alignment over time. Stability is determined using binary outcomes (yes/no) based on whether the absolute difference in lens position between baseline (Form 0) and follow-up visit (Form 5) remains within predefined thresholds.
Time frame: Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390
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