CataractIChopperNCT07840885
Illuminated Chopper in Cataract Surgery
A study testing iChopper Illumination Chopper and iVision Light Source and Conventional Microscope Illumination in people with Cataract, run by YES Eye Clinic at 1 site in United States.
Trial summary
This study compares cataract surgery performed with an illuminated chopper and intracameral illumination with cataract surgery performed under conventional external coaxial microscope illumination. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- iChopper Illumination Chopper and iVision Light Source and Conventional Microscope Illumination
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older
- Diagnosis of bilateral cataract
- Both eyes suitable for cataract surgery
- Expected postoperative best-corrected visual acuity of 0.2 Snellen or better
- No other secondary ocular surgeries planned during the study period
- Ability to comply with all study procedures and follow-up visits
- Ability and willingness to provide written informed consent
Who cannot join
- Preoperative ocular or systemic conditions, or medication use, that may affect study outcomes, increase risk to the participant, or predispose to complications, including infectious disease, ocular atrophy, or zonular weakness
- Poorly controlled diabetes mellitus
- Use of alpha-blockers such as tamsulosin for benign prostatic hyperplasia
- Planned femtosecond laser-assisted cataract surgery
- Congenital ocular disorders
- History of ophthalmic surgery in either eye that may affect study outcomes or increase risk, including retinal surgery, glaucoma surgery, or anterior segment surgery
- Inability to provide informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized, Paired-Eye, Comparative Study Between Cataract Surgeries With and Without an Illuminated Chopper
This study compares cataract surgery performed with an illuminated chopper and intracameral illumination with cataract surgery performed under conventional external coaxial microscope illumination. Participants undergoing bilateral cataract surgery will have one eye treated with the illuminated chopper and the other eye treated without the illuminated chopper, with the order randomized between eyes.
The study will evaluate differences in operation time, pupil size, the need for additional intraocular medications or devices, intraoperative and postoperative complications, and postoperative clinical outcomes including visual acuity and intraocular pressure.
Read the detailed description
This is a prospective, randomized, paired-eye comparative clinical study in participants undergoing bilateral cataract surgery. Each participant will undergo cataract surgery in both eyes. One eye will be treated using the iChopper illumination chopper with the iVision light source, while the fellow eye will undergo cataract surgery using conventional external coaxial microscope illumination. The order of the surgical method between the right and left eyes will be randomized.
The illuminated chopper provides intracameral illumination during cataract surgery and is designed to improve visualization of intraocular structures while also functioning as a lens chopper. The investigational device has received U.S. FDA 510(k) clearance.
The study will assess intraoperative outcomes including operation time, pupil size, ultrasound usage time, pupil-related surgical difficulties, intraoperative complications, and the use of additional intraocular medications or devices. Postoperative assessments will include visual acuity, manifest refraction, intraocular pressure, and postoperative complications.
Participants will undergo bilateral cataract surgery with the two procedures scheduled approximately 1 to 3 weeks apart. Follow-up assessments will be performed approximately 1 day and 30 days after surgery for each eye.
- Conditions
- Cataract
- Being tested
- iChopper Illumination Chopper and iVision Light Source, Conventional Microscope Illumination
- Keywords
- Illuminated chopper, Cataract, Phacoemulsification, Clinical outcome
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iChopper Illumination Chopper and iVision Light SourceDevice
Cataract surgery is performed using the iChopper illumination chopper with the iVision light source to provide intracameral illumination during phacoemulsification.
Conventional Microscope IlluminationProcedure or surgery
Cataract surgery is performed under conventional external coaxial illumination from the surgical microscope without use of the illuminated chopper.
| Study group | Role | What they receive |
|---|---|---|
| Illuminated Chopper in Right Eye | Experimental | Participants assigned to this arm undergo cataract surgery using the illuminated chopper in the right eye and cataract surgery under conventional external coaxial microscope illumination in the left eye. Receives: Device: iChopper Illumination Chopper and iVision Light Source; Procedure: Conventional Microscope Illumination |
| Illuminated Chopper in Left Eye | Experimental | Participants assigned to this arm undergo cataract surgery under conventional external coaxial microscope illumination in the right eye and cataract surgery using the illuminated chopper in the left eye. Receives: Device: iChopper Illumination Chopper and iVision Light Source; Procedure: Conventional Microscope Illumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation Time
Operation time during cataract surgery will be recorded and compared between eyes undergoing surgery with the illuminated chopper and eyes undergoing surgery with conventional microscope illumination.
Measured: During cataract surgery
Pupil Size During Cataract Surgery
Pupil size during cataract surgery will be assessed and compared between the illuminated chopper and conventional microscope illumination conditions.
Measured: During cataract surgery
Use of Additional Intraocular Medications
The use of additional intraocular medications during cataract surgery will be recorded and compared between the illuminated chopper and conventional microscope illumination conditions.
Measured: During cataract surgery
Use of Additional Intraocular Devices
The use of additional intraocular devices during cataract surgery will be recorded and compared between the illuminated chopper and conventional microscope illumination conditions.
Measured: During cataract surgery
Secondary outcomes (4)
Intraoperative Complications
Intraoperative complications occurring during cataract surgery, including pupil-related and other surgical complications, will be recorded and compared between the two surgical conditions.
Measured: During cataract surgery
Postoperative Complications
Postoperative complications following cataract surgery will be recorded and compared between eyes treated with and without the illuminated chopper.
Measured: From surgery through approximately 30 days after surgery
Postoperative Distance Visual Acuity
Distance visual acuity will be assessed after cataract surgery and compared between the illuminated chopper and conventional microscope illumination conditions.
Measured: Day 1 and Day 30 after surgery
Postoperative Intraocular Pressure
Intraocular pressure will be assessed during postoperative follow-up and compared between the illuminated chopper and conventional microscope illumination conditions.
Measured: Day 1 and Day 30 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start14 Sep 2023
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, paired-eye study in which each participant undergoes bilateral cataract surgery. One eye is assigned to cataract surgery using the illuminated chopper, and the fellow eye is assigned to cataract surgery without the illuminated chopper under conventional microscope illumination. The right-left eye assignment is randomized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- YES Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Heun Nam, MD, PhD, Study director, Gachon University Gil Medical Center, College of Medicine, Incheon, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840885
- Sponsor's protocol ID
- OCL-IIC-01
- Other IDs
- RS-2022-00141533
- Acronym
- IChopper
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication, subject to review by the study investigators and sponsor and in accordance with applicable ethical, privacy, and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized, Paired-Eye, Comparative Study Between Cataract Surgeries With and Without an Illuminated Chopper
- ClinicalTrials.gov ID
- NCT07840885
- Acronym / sponsor ID
- IChopper / OCL-IIC-01
- Conditions
- Cataract
- Keywords
- Illuminated chopper, Cataract, Phacoemulsification, Clinical outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- YES Eye ClinicUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 25 Sep 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 compares cataract surgery performed with an illuminated chopper and intracameral illumination with cataract surgery performed under conventional external coaxial microscope illumination. Participants undergoing bilateral cataract surgery will have one eye treated with the illuminated chopper and the other eye treated without the illuminated chopper, with the order randomized between eyes.
The study will evaluate differences in operation time, pupil size, the need for additional intraocular medications or devices, intraoperative and postoperative complications, and postoperative clinical outcomes including visual acuity and intraocular pressure.
Detailed description
This is a prospective, randomized, paired-eye comparative clinical study in participants undergoing bilateral cataract surgery. Each participant will undergo cataract surgery in both eyes. One eye will be treated using the iChopper illumination chopper with the iVision light source, while the fellow eye will undergo cataract surgery using conventional external coaxial microscope illumination. The order of the surgical method between the right and left eyes will be randomized.
The illuminated chopper provides intracameral illumination during cataract surgery and is designed to improve visualization of intraocular structures while also functioning as a lens chopper. The investigational device has received U.S. FDA 510(k) clearance.
The study will assess intraoperative outcomes including operation time, pupil size, ultrasound usage time, pupil-related surgical difficulties, intraoperative complications, and the use of additional intraocular medications or devices. Postoperative assessments will include visual acuity, manifest refraction, intraocular pressure, and postoperative complications.
Participants will undergo bilateral cataract surgery with the two procedures scheduled approximately 1 to 3 weeks apart. Follow-up assessments will be performed approximately 1 day and 30 days after surgery for each eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized, paired-eye study in which each participant undergoes bilateral cataract surgery. One eye is assigned to cataract surgery using the illuminated chopper, and the fellow eye is assigned to cataract surgery without the illuminated chopper under conventional microscope illumination. The right-left eye assignment is randomized.
| Arm | Type | Receives |
|---|---|---|
| Illuminated Chopper in Right Eye | Experimental | Device: iChopper Illumination Chopper and iVision Light Source, Procedure: Conventional Microscope IlluminationParticipants assigned to this arm undergo cataract surgery using the illuminated chopper in the right eye and cataract surgery under conventional external coaxial microscope illumination in the left eye. |
| Illuminated Chopper in Left Eye | Experimental | Device: iChopper Illumination Chopper and iVision Light Source, Procedure: Conventional Microscope IlluminationParticipants assigned to this arm undergo cataract surgery under conventional external coaxial microscope illumination in the right eye and cataract surgery using the illuminated chopper in the left eye. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40 years or older
- Diagnosis of bilateral cataract
- Both eyes suitable for cataract surgery
- Expected postoperative best-corrected visual acuity of 0.2 Snellen or better
- No other secondary ocular surgeries planned during the study period
Key exclusion criteria (8 listed)
- Preoperative ocular or systemic conditions, or medication use, that may affect study outcomes, increase risk to the participant, or predispose to complications, including infectious disease, ocular atrophy, or zonular weakness
- Poorly controlled diabetes mellitus
- Use of alpha-blockers such as tamsulosin for benign prostatic hyperplasia
- Planned femtosecond laser-assisted cataract surgery
- Congenital ocular disorders
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 |
|---|---|---|
| iChopper Illumination Chopper and iVision Light SourceCataract surgery is performed using the iChopper illumination chopper with the iVision light source to provide intracameral illumination during phacoemulsification. | Device | Illuminated Chopper in Left Eye, Illuminated Chopper in Right Eye |
| Conventional Microscope IlluminationCataract surgery is performed under conventional external coaxial illumination from the surgical microscope without use of the illuminated chopper. | Procedure or surgery | Illuminated Chopper in Left Eye, Illuminated Chopper in Right Eye |
Primary outcome
Operation Time
Time frame: During cataract surgery
Operation time during cataract surgery will be recorded and compared between eyes undergoing surgery with the illuminated chopper and eyes undergoing surgery with conventional microscope illumination.
Pupil Size During Cataract Surgery
Time frame: During cataract surgery
Pupil size during cataract surgery will be assessed and compared between the illuminated chopper and conventional microscope illumination conditions.
Use of Additional Intraocular Medications
Time frame: During cataract surgery
The use of additional intraocular medications during cataract surgery will be recorded and compared between the illuminated chopper and conventional microscope illumination conditions.
Use of Additional Intraocular Devices
Time frame: During cataract surgery
The use of additional intraocular devices during cataract surgery will be recorded and compared between the illuminated chopper and conventional microscope illumination conditions.
4 secondary outcomes
Intraoperative Complications
Time frame: During cataract surgery
Postoperative Complications
Time frame: From surgery through approximately 30 days after surgery
Postoperative Distance Visual Acuity
Time frame: Day 1 and Day 30 after surgery
Postoperative Intraocular Pressure
Time frame: Day 1 and Day 30 after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication, subject to review by the study investigators and sponsor and in accordance with applicable ethical, privacy, and regulatory requirements.
Related trials for Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
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. This study is not recruiting at the moment.
Dong Heun Nam, MD, PhD study director
Gachon University Gil Medical Center, College of Medicine, Incheon, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iChopper Illumination Chopper and iVision Light Source and Conventional Microscope Illumination in people with Cataract, run by YES Eye Clinic at 1 site 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation Time (time frame: During cataract surgery). The study lists 4 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 2 Oct 2026.