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Active, not recruitingNCT07768475Updated Aug 17, 2026

A Prospective Study Comparing Visual Outcomes and Patient Satisfaction Following Implantation of the Clareon PanOptix Versus Tecnis Odyssey IOL in Patients Undergoing Cataract Surgery.

An interventional study of Intraocular Lens Implant and Intraocular Lens Implant in Cataracts, sponsored by Nvision Laser Eye Centers. Active, not recruiting at 4 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Nvision Laser Eye Centers · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jul 2025, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
266
Allocation
Randomized
Sex
All
01

Study 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 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)

02

Conditions studied

  • Cataracts

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Keywords

  • Cataracts
  • PanOptix
  • Odyssey
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 266 is above the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Nvision Laser Eye Centers is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing and able to understand and sign
  2. Willing and able to participate with all study testing
  3. Adult patient diagnosed with age-related cataracts bilaterally
  4. 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)
  5. 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
  6. 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)
  7. Normal ocular findings aside from cataract

Exclusion criteria

Exclusion Criteria:

  1. HOA greater than 0.4 μm within central 4 mm
  2. Corneal dystrophies, degenerations, irregular astigmatism or any corneal abnormality aside from regular astigmatism deemed to be of clinical significance by the surgeon.
  3. Any pathologic conditions that might affect ease of cataract removal (pseudoexfoliation, posterior polar, etc) as determined by surgeon
  4. Strabismus with or without amblyopia in either eye
  5. Previous history of any ocular surgery including corneal refractive surgery
  6. Presence of any macular disease, history of retinal detachment, or posterior segment abnormality deemed to be of clinical significance by the surgeon.
  7. Presence of glaucoma
  8. 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, disease, etc).
  9. Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
  10. 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
266 participants (actual)

Study arms

  • Active comparator
    Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)

    One of 2 IOLs being used in the study

    Device: Intraocular Lens Implant

  • Active comparator
    Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225

    One of 2 IOLs being used in the study

    Device: Intraocular Lens Implant

Interventions

  • DeviceIntraocular Lens Implant

    Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 \& 4 (BLF)

  • DeviceIntraocular Lens Implant

    Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225

06

What researchers measure

Primary outcomes

  1. Binocular BCDVA

    Binocular BCDVA at 4 m under photopic conditions

    Time frame: At Visit 2 Month 3

Secondary outcomes

  1. 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

    Time frame: Visit 2 Month 3

  2. 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

    Time frame: Visit 2 Month 3

07

Study locations

4 sites
  • Hyperspeed LASIK
    Rowland Heights, California 91748, United States
  • Seeta Eye Center
    Poughkeepsie, New York 12603, United States
  • Texas Eye and Laser Center
    Hurst, Texas 76054, United States
  • Parkhurst Nuvision
    San Antonio, Texas 78229, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Oct 2026, 15 months after the start.

Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's planned 15 months is close to that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 17, 2026
StartActual
Jul 7, 2025
Primary completionEst.
Oct 12, 2026
CompletionEst.
Nov 12, 2026
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07768475
Lead sponsor
Nvision Laser Eye Centers
Responsible party
Sponsor
First posted
Aug 17, 2026
Start date
Jul 7, 2025
Primary completion
Oct 12, 2026 (estimated)
Completion
Nov 12, 2026 (estimated)
Last update
Aug 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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