Eye DiseasesNCT06399211
Investigation of the Safety and Effectiveness of Monofocal Toric Intraocular Lens (IOL)
A study testing PODEYE TORIC Monofocal IOL and Alcon AcrySof SA60AT Monofocal IOL in people with Eye Diseases and Postcataract Aphakia, run by Beaver-Visitec International, Inc..
Trial summary
This study is a prospective, multicenter, randomized, double masked trial comparing an investigational Monofocal Toric intraocular lens (IOL) (PODEYE TORIC CYL 1.5 D) and a commercially available non-toric monofocal IOL. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Eye Diseases, Postcataract Aphakia, Cataract
- What is being tested?
- PODEYE TORIC Monofocal IOL and Alcon AcrySof SA60AT Monofocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2024to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female adults, age 22 years or older at the Preoperative Visit.
- Clinically significant cataract in the study eye eligible for standard phacoemulsification cataract surgery.
- Eligible for receipt of an IOL power within the range of the investigational IOL in the study eye. (The Investigational IOL is available in powers from +15 D to +30 D Spherical Equivalent)
- Pre-operative corneal astigmatism in the range: ≥0.75 D and ≤1.50 D in the study eye
- Anticipated residual astigmatism of ≤0.3 D in the study eye as determined by the Toric Calculator.
- Clear intraocular media other than cataract in the study eye.
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- Best corrected visual acuity equal to or worse than 0.3 logMAR, with or without a glare source in the study eye.
- Ability to dilate pupil sufficiently (greater than or equal to 6.0 mm) to allow visualization of Toric IOL axis markings post-implantation in the study eye.
- Projected BCDVA of 0.2 logMAR (20/32 Snellen) or better in the study eye after cataract surgery/IOL implantation, as determined by the medical judgment of the Investigator.
- Contact lens users must be willing to discontinue wear of their lenses in the study eye in accordance with the following requirements:
- Rigid gas permeable and toric lenses for ≥ 7 days prior to the Preoperative Visit
- Soft non-toric contact lenses for ≥ 3 days prior to the Preoperative Visit
- All contact lens wearers must demonstrate a stable refraction within ± 0.50 D MRSE and 15 degrees astigmatic axis, on two consecutive examinations at least 1 week apart in an eye to be treated.
- Provide signed written consent prior to participation in any study-related procedures.
- Ability, comprehension, and willingness to follow study instructions, and to complete all study visits.
- Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Who cannot join
- · Subjects with irregular corneal astigmatism in the study eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
- Subjects with clinically significant corneal pathology potentially affecting corneal topography in the study eye.
- Subjects with a traumatic cataract in the study eye.
- Subjects with uncontrolled glaucoma in the study eye.
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 0.2 logMAR or worse in the study eye.
- Subjects with conditions associated with increased risk of zonular rupture during the cataract extraction procedure which may affect the postoperative centration or tilt of the lens in the study eye.
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- Significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) in the study eye.
- Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in study eye during the study participation period.
- Presence of one or more clinically significant corneal abnormalities in study eye, including corneal dystrophy, irregularity, or edema.
- Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in the study eye.
- Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.
- Subjects with potential BCDVA of 20/200 or worse in the fellow eye.
- Subjects with a difference of greater than 0.50 D of corneal astigmatism as measured with the IOL master/Lenstar/Argos and the topographer in the study eye using vector analysis.
- Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in the study eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits.
- Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit.
- Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
- Pregnant or nursing females
About this study
Official title: Clinical Investigation of the Safety and Effectiveness of Monofocal PODEYE TORIC Intraocular Lens (IOL)
This study is a prospective, multicenter, randomized, double masked trial comparing an investigational Monofocal Toric intraocular lens (IOL) (PODEYE TORIC CYL 1.5 D) and a commercially available non-toric monofocal IOL.
Read the detailed description
The study will include adult subjects with operable cataract in at least one eye along with pre-existing corneal astigmatism who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
- Conditions
- Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities, Astigmatism
- Being tested
- PODEYE TORIC Monofocal IOL, Alcon AcrySof SA60AT Monofocal IOL
- Keywords
- Intraocular Lens, Monofocal, Toric, Hydrophobic
- Medical subject headings
- Eye Diseases, Aphakia, Postcataract, Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PODEYE TORIC Monofocal IOLDevice
Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag.
Alcon AcrySof SA60AT Monofocal IOLDevice
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SA60AT Monofocal IOL will be implanted in the capsular bag.
| Study group | Role | What they receive |
|---|---|---|
| PODEYE TORIC IOL (1.5 D) | Experimental | Cataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag. Receives: Device: PODEYE TORIC Monofocal IOL |
| Control IOL | Active comparator | Cataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag. Receives: Device: Alcon AcrySof SA60AT Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.
Residual Cylinder in Diopters as measured by Manifest Refraction
Measured: Form 4 visit (window: 120-180 days)
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 10 Degrees (Toric IOL Arm Only)
Intraocular lens (IOL) axis misalignment of less than 10 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Measured: Form 4 visit (window: 120-180 days)
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 20 Degrees (Toric IOL Arm Only)
Intraocular lens (IOL) axis misalignment of less than 20 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Measured: Form 4 visit (window: 120-180 days)
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than or Equal to 5 Degrees (Toric IOL Arm Only)
Intraocular Lens (IOL) rotation of less than or equal to five degrees between Form 3 visit (window: 30-60 days) and Form 4 visit (window: 120-180 days)
Measured: Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start28 Jun 2024
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eye DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Up to 300 subjects shall be screened and approximately 230 subjects will be randomized and implanted at up to 10 clinical sites in USA. Subjects who meet all protocol-specified eligibility criteria will be randomized at a 1:1 ratio to receive either the PODEYE TORIC CYL 1.5 D IOL (test) or the control IOL in the study eye.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399211
- Sponsor's protocol ID
- PHY2302
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Safety and Effectiveness of Monofocal PODEYE TORIC Intraocular Lens (IOL)
- ClinicalTrials.gov ID
- NCT06399211
- Acronym / sponsor ID
- PHY2302
- Conditions
- Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities, Astigmatism
- Keywords
- Intraocular Lens, Monofocal, Toric, Hydrophobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Posted 22 Apr 2026
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 a prospective, multicenter, randomized, double masked trial comparing an investigational Monofocal Toric intraocular lens (IOL) (PODEYE TORIC CYL 1.5 D) and a commercially available non-toric monofocal IOL.
Detailed description
The study will include adult subjects with operable cataract in at least one eye along with pre-existing corneal astigmatism who are eligible for phacoemulsification cataract surgery followed by IOL implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Up to 300 subjects shall be screened and approximately 230 subjects will be randomized and implanted at up to 10 clinical sites in USA. Subjects who meet all protocol-specified eligibility criteria will be randomized at a 1:1 ratio to receive either the PODEYE TORIC CYL 1.5 D IOL (test) or the control IOL in the study eye.
| Arm | Type | Receives |
|---|---|---|
| PODEYE TORIC IOL (1.5 D) | Experimental | Device: PODEYE TORIC Monofocal IOLCataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag. |
| Control IOL | Active comparator | Device: Alcon AcrySof SA60AT Monofocal IOLCataractous lens will be removed in the study eyes and the control IOL will be implanted in the capsular bag. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female adults, age 22 years or older at the Preoperative Visit.
- Clinically significant cataract in the study eye eligible for standard phacoemulsification cataract surgery.
- Eligible for receipt of an IOL power within the range of the investigational IOL in the study eye. (The Investigational IOL is available in powers from +15 D to +30 D Spherical Equivalent)
- Pre-operative corneal astigmatism in the range: ≥0.75 D and ≤1.50 D in the study eye
- Anticipated residual astigmatism of ≤0.3 D in the study eye as determined by the Toric Calculator.
Key exclusion criteria (17 listed)
- · Subjects with irregular corneal astigmatism in the study eye (Note: corneal incisions intended to reduce astigmatism are not permitted)
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 |
|---|---|---|
| PODEYE TORIC Monofocal IOLCataractous lens will be removed in the study eyes and the PODEYE TORIC IOL (1.5 D) will be implanted in the capsular bag. | Device | PODEYE TORIC IOL (1.5 D) |
| Alcon AcrySof SA60AT Monofocal IOLCataractous lens will be removed in the study eyes and the Alcon AcrySof SA60AT Monofocal IOL will be implanted in the capsular bag. | Device | Control IOL |
Primary outcome
Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms.
Time frame: Form 4 visit (window: 120-180 days)
Residual Cylinder in Diopters as measured by Manifest Refraction
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 10 Degrees (Toric IOL Arm Only)
Time frame: Form 4 visit (window: 120-180 days)
Intraocular lens (IOL) axis misalignment of less than 10 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than 20 Degrees (Toric IOL Arm Only)
Time frame: Form 4 visit (window: 120-180 days)
Intraocular lens (IOL) axis misalignment of less than 20 degrees at 4 to 6 months compared to the intended IOL axis of orientation at the operative visit after the surgery
Percentage of Participants With Intraocular Lens (IOL) Axis Misalignment of Less Than or Equal to 5 Degrees (Toric IOL Arm Only)
Time frame: Form 3 Visit (window: 30-60 days), Form 4 Visit (window: 120-180 days)
Intraocular Lens (IOL) rotation of less than or equal to five degrees between Form 3 visit (window: 30-60 days) and Form 4 visit (window: 120-180 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PODEYE TORIC Monofocal IOL and Alcon AcrySof SA60AT Monofocal IOL in people with Eye Diseases and Postcataract Aphakia, run by Beaver-Visitec International, Inc..
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 16 inclusion and 17 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Residual Manifest Cylinder in Diopters in Toric and Control Arms. (time frame: Form 4 visit (window: 120-180 days)). 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 22 Apr 2026.