Aphakia, Postcataract
Conditions
Brief summary
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.
Interventions
DEVICEKI-362-US1 (YP2.2VM)
Injector and one-piece (1P) monofocal IOL
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are able and willing to provide written informed consent, attend all scheduled visits, and comply with all trial procedures and follow-up * Have a study eye with visually significant cataract for which phacoemulsification cataract extraction and posterior chamber IOL implantation is indicated * Meet all other inclusion criteria outlined in the clinical study protocol
Exclusion criteria
* Have serious systemic disease that could increase operative risk or conditions that can confound the surgical outcome * Within 30 days of the Screening Visit, use of systemic medications with significant ocular side effects or any medications that could confound the outcome or increase participant risk * Meet any other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants whose BCDVA Achieved 0.30 logMAR or Better at Form 5 | Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390 | 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 |
| Proportion of Participants with Incidence of Selected Ocular Adverse Events | Baseline through end of study (up to 15 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 4 | Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180 | 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. |
| Proportion of Participants with Lens Axis Misalignment of <10 degrees From Baseline to Form 5 | Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390 | 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. |
| Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 4 | Baseline (Form 0) through Visit 4 (Form 4), approximately Days 120-180 | 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. |
| Proportion of Participants with Lens Axis Misalignment of <20 degrees From Baseline to Form 5 | Baseline (Form 0) through Visit 5 (Form 5), approximately Days 330-390 | 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. |
Contacts
CONTACTDirector, Clinical Operations
STUDY_CHAIRShona Pendse, MD, MMSc
Kowa Research Institute, Inc.
Outcome results
None listed