CataractsNCT07768475
A Prospective Study Comparing Visual Outcomes and Patient Satisfaction Following Implantation of the Clareon PanOptix Versus Tecnis Odyssey IOL in Patients Undergoing Cataract Surgery.
A study testing Intraocular Lens Implant in people with Cataracts, run by Nvision Laser Eye Centers at 4 sites in United States.
Trial summary
To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataracts
- What is being tested?
- Intraocular Lens Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jul 2025to 12 Nov 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to understand and sign informed consent
- Willing and able to participate with all study testing
- Adult patient diagnosed with age-related cataracts bilaterally
- Planned bilateral cataract removal by phacoemulsification with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric or Tecnis Odyssey IOL/ Tecnis Odyssey IOL Toric (T3/4 or DRT150, DRT225)
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon
- Residual astigmatism expected to be ≤ 0.50 diopters in both eyes postoperatively as determined by surgeon (After using either toric IOL or arcuate incision with laser)
- Normal ocular findings aside from cataract
Who cannot join
- HOA greater than 0.4 μm within central 4 mm
- Corneal dystrophies, degenerations, irregular astigmatism or any corneal abnormality aside from regular astigmatism deemed to be of clinical significance by the surgeon.
- Any pathologic conditions that might affect ease of cataract removal (pseudoexfoliation, posterior polar, etc) as determined by surgeon
- Strabismus with or without amblyopia in either eye
- Previous history of any ocular surgery including corneal refractive surgery
- Presence of any macular disease, history of retinal detachment, or posterior segment abnormality deemed to be of clinical significance by the surgeon.
Show all 10Show fewer
- Presence of glaucoma
- Presence of any acute or chronic systemic disease that would confound the results of this study as determined by the surgeon (e.g. uncontrolled diabetes, immunocompromise, autoimmune disease, etc).
- Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
- Any subjects with intraoperative complications, including vitreous loss, posterior capsular rupture, zonular dialysis, decentered or tilted IOL, diffuse corneal epithelial defect, and use of iris hooks or expanders, will be excluded from analysis.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Eye and Laser Center
Hurst, Texas, 76054
Seeta Eye Center
Poughkeepsie, New York, 12603
Hyperspeed LASIK
Rowland Heights, California, 91748
Parkhurst Nuvision
San Antonio, Texas, 78229
About this study
To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery
Read the detailed description
Multi-center, one-arm, ambispective pilot study with Odyssey IOL followed by a multi-center, prospective, randomized, two-arm, double-masked (subject and assessor), Clareon PanOptix vs TECNIS Odyssey comparative study with bilateral IOL implantation (endpoints or sample size may be modified after the pilot data analysis)
- Conditions
- Cataracts
- Being tested
- Intraocular Lens Implant
- Keywords
- Cataracts, PanOptix, Odyssey
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular Lens ImplantDevice
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 \& 4 (BLF)
Intraocular Lens ImplantDevice
Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225
| Study group | Role | What they receive |
|---|---|---|
| Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF) | Active comparator | One of 2 IOLs being used in the study Receives: Device: Intraocular Lens Implant |
| Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225 | Active comparator | One of 2 IOLs being used in the study Receives: Device: Intraocular Lens Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular BCDVA
Binocular BCDVA at 4 m under photopic conditions
Measured: At Visit 2 Month 3
Secondary outcomes (2)
Visual Acuity
Monocular BCDVA at 4 m under photopic conditions Monocular DCIVA at 60 cm under photopic conditions Monocular DCNVA at 33 cm under photopic conditions Monocular DCNVA at 40 cm under photopic conditions Binocular DCNVA at 33 cm under photopic conditions Binocular DCNVA at 40 cm under photopic conditions Binocular DCIVA at 60 cm under photopic conditions Binocular UDVA at 4 m under photopic conditions Binocular UIVA at 60 cm under photopic conditions Binocular UNVA at 40 cm under photopic conditions Binocular UNVA at 33 cm under photopic conditions Mean residual spherical equivalent (MRSE) Mean residual cylinder
% of eyes achieving MRSE within ± 0.50 D of target (emmetropia) Mean area under binocular photopic best distance corrected defocus curves Mean area under monocular photopic best distance corrected defocus curves
Measured: Visit 2 Month 3
Visual Acuity
Binocular DCNVA at 33 cm under mesopic conditions Binocular DCNVA at 40 cm under mesopic conditions Binocular DCIVA at 60 cm under mesopic conditions Low Contrast Binocular (25%) DCNVA at 40 cm under mesopic conditions Low Contrast Binocular (25%) DCNVA at 40 cm under photopic conditions Low Contrast Binocular (25%) DCIVA at 60 cm under mesopic conditions Low Contrast Binocular (25%) DCIVA at 60 cm under photopic conditions Binocular best distance corrected contrast sensitivity (with and without glare) measurements under photopic and mesopic conditions
- patients complaining of bothersome visual disturbances (haloes glare and starbursts QUVID)
- complete spectacle independence IOLSAT
- patients who were satisfied with their vision IOLSAT
Measured: Visit 2 Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start7 Jul 2025
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nvision Laser Eye Centers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768475
- Sponsor's protocol ID
- NVision Zhu Head to Head IIT
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Visual Outcomes and Patient Satisfaction Following Implantation of the Clareon PanOptix Versus Tecnis Odyssey IOL in Patients Undergoing Cataract Surgery.
- ClinicalTrials.gov ID
- NCT07768475
- Acronym / sponsor ID
- NVision Zhu Head to Head IIT
- Conditions
- Cataracts
- Keywords
- Cataracts, PanOptix, Odyssey
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Nvision Laser Eye CentersIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 17 Aug 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.
To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery
Detailed description
Multi-center, one-arm, ambispective pilot study with Odyssey IOL followed by a multi-center, prospective, randomized, two-arm, double-masked (subject and assessor), Clareon PanOptix vs TECNIS Odyssey comparative study with bilateral IOL implantation (endpoints or sample size may be modified after the pilot data analysis)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF) | Active comparator | Device: Intraocular Lens ImplantOne of 2 IOLs being used in the study |
| Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225 | Active comparator | Device: Intraocular Lens ImplantOne of 2 IOLs being used in the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to understand and sign informed consent
- Willing and able to participate with all study testing
- Adult patient diagnosed with age-related cataracts bilaterally
- Planned bilateral cataract removal by phacoemulsification with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric or Tecnis Odyssey IOL/ Tecnis Odyssey IOL Toric (T3/4 or DRT150, DRT225)
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon
Key exclusion criteria (10 listed)
- HOA greater than 0.4 μm within central 4 mm
- Corneal dystrophies, degenerations, irregular astigmatism or any corneal abnormality aside from regular astigmatism deemed to be of clinical significance by the surgeon.
- Any pathologic conditions that might affect ease of cataract removal (pseudoexfoliation, posterior polar, etc) as determined by surgeon
- Strabismus with or without amblyopia in either eye
- Previous history of any ocular surgery including corneal refractive surgery
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 |
|---|---|---|
| Intraocular Lens ImplantClareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 \& 4 (BLF) | Device | Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF) |
| Intraocular Lens ImplantTecnis® Odyssey® IOL models DRN00V, DRT150, DRT225 | Device | Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225 |
Primary outcome
Binocular BCDVA
Time frame: At Visit 2 Month 3
Binocular BCDVA at 4 m under photopic conditions
2 secondary outcomes
Visual Acuity
Time frame: Visit 2 Month 3
Visual Acuity
Time frame: Visit 2 Month 3
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 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cataracts
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingObservational study
Postoperative Outcome Verification of Discrepant Toric IOL Calculator Recommendations After Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraocular Lens Implant in people with Cataracts, run by Nvision Laser Eye Centers at 4 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Binocular BCDVA (time frame: At Visit 2 Month 3). 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 17 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.