Aphakia, PostcataractNCT07650201
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
A study testing KI-362-US1 (YP2.2VM) in people with Aphakia, Postcataract, run by Kowa Research Institute, Inc. at 9 sites in United States.
Trial summary
This study is designed to evaluate how well an artificial lens, called an intraocular lens (IOL), performs in adults undergoing cataract surgery. During cataract surgery, the eye's natural lens is removed and replaced with an artificial lens to improve vision. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Postcataract
- What is being tested?
- KI-362-US1 (YP2.2VM)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 exclusion criteria outlined in the clinical study protocol
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210
North Georgia Eye Associates
Gainesville, Georgia, 30501
Icon EyeCare
Grand Junction, Colorado, 81501
Houston Eye Associates, North Loop
Houston, Texas, 77008
Berkeley Eye
Houston, Texas, 77027
Texas Eye Research
Hurst, Texas, 76054
Piedmont Eye Center
Lynchburg, Virginia, 24502
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, 29464
Ophthalmology Consultants Ltd
St Louis, Missouri, 63128
About this study
Official title: A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction
This study is designed to evaluate how well an artificial lens, called an intraocular lens (IOL), performs in adults undergoing cataract surgery. During cataract surgery, the eye's natural lens is removed and replaced with an artificial lens to improve vision.
The main goal of the study is to evaluate participants' vision after the IOL is placed in the eye. Approximately one year after surgery, participants' vision will be assessed to determine how clearly they can see.
The results of this study will provide additional information about the performance of the IOL in adults undergoing cataract surgery.
- Conditions
- Aphakia, Postcataract
- Being tested
- KI-362-US1 (YP2.2VM)
- Medical subject headings
- Aphakia, Postcataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KI-362-US1 (YP2.2VM)Device
Injector and one-piece (1P) monofocal IOL
| Study group | Role | What they receive |
|---|---|---|
| KI-362-US1 | Experimental | Participants receive an intraocular lens (IOL) implanted during cataract surgery to replace the natural lens of the eye. The IOL is delivered using a single-use, preloaded delivery device and positioned within the eye's natural lens capsule. Receives: Device: KI-362-US1 (YP2.2VM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving a Predefined BCDVA Criterion at Visit 5
Proportion of participants achieving a predefined best-corrected distance visual acuity (BCDVA) criterion, as measured using Early Treatment Diabetic Retinopathy Study (ETDRS) illuminated charts at postoperative days 330-390 (Visit 5, Form 5).
Measured: Baseline through Visit 5, approximately Days 330-390.
Proportion of Participants With Selected Ocular Adverse Events
Proportion of participants experiencing one or more predefined ocular adverse events following treatment, including both cumulative and persistent events. Events are assessed based on their occurrence or persistence during the study period.
Measured: Baseline through end of study (up to 15 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphakia, PostcataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shona Pendse, MD, MMSc, Study chair, Kowa Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650201
- Sponsor's protocol ID
- KI-362-US1-301
- Status last verified
- Nov 2026
- First submitted
- 10 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Single-arm Clinical Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) IOL for Correction of Aphakia Following Cataract Extraction
- ClinicalTrials.gov ID
- NCT07650201
- Acronym / sponsor ID
- KI-362-US1-301
- Conditions
- Aphakia, Postcataract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate how well an artificial lens, called an intraocular lens (IOL), performs in adults undergoing cataract surgery. During cataract surgery, the eye's natural lens is removed and replaced with an artificial lens to improve vision.
The main goal of the study is to evaluate participants' vision after the IOL is placed in the eye. Approximately one year after surgery, participants' vision will be assessed to determine how clearly they can see.
The results of this study will provide additional information about the performance of the IOL in adults undergoing cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KI-362-US1 | Experimental | Device: KI-362-US1 (YP2.2VM)Participants receive an intraocular lens (IOL) implanted during cataract surgery to replace the natural lens of the eye. The IOL is delivered using a single-use, preloaded delivery device and positioned within the eye's natural lens capsule. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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 exclusion criteria outlined in the clinical study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KI-362-US1 (YP2.2VM)Injector and one-piece (1P) monofocal IOL | Device | KI-362-US1 |
Primary outcome
Proportion of Participants Achieving a Predefined BCDVA Criterion at Visit 5
Time frame: Baseline through Visit 5, approximately Days 330-390.
Proportion of participants achieving a predefined best-corrected distance visual acuity (BCDVA) criterion, as measured using Early Treatment Diabetic Retinopathy Study (ETDRS) illuminated charts at postoperative days 330-390 (Visit 5, Form 5).
Proportion of Participants With Selected Ocular Adverse Events
Time frame: Baseline through end of study (up to 15 months)
Proportion of participants experiencing one or more predefined ocular adverse events following treatment, including both cumulative and persistent events. Events are assessed based on their occurrence or persistence during the study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Aphakia, Postcataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shona Pendse, MD, MMSc study chair
Kowa Research Institute, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KI-362-US1 (YP2.2VM) in people with Aphakia, Postcataract, run by Kowa Research Institute, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director, Clinical Operations (919-433-1600, Clinical@KowaUS.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving a Predefined BCDVA Criterion at Visit 5 (time frame: Baseline through Visit 5, approximately Days 330-390.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.