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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KI-362-US1 | Experimental | Participants in this study receive an artificial lens (intraocular lens) implanted in the eye to replace the eye's natural lens that has been removed due to cataract surgery. The lens is delivered using a single-use, preloaded device that helps the surgeon place the lens safely and precisely into the natural lens capsule of the eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KI-362-US1 (YP2.2VM) | Device | Injector and one-piece (1P) monofocal IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline through end of study (up to 15 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Contact | 919-433-1600 | Clinical@KowaUS.com |
| Name | Affiliation | Role |
|---|---|---|
| Shona Pendse, MD, MMSc | Kowa Research Institute, Inc. | Study Chair |
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| 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. | 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. | 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. | Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390 |
| ID | Term |
|---|---|
| D001036 | Aphakia, Postcataract |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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