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OpenTrials
Active, not recruiting

NCT Number: NCT07768475

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

To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hyperspeed LASIK, Rowland Heights, California, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Intraocular Lens Implant

Device

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

Primary outcomes

  1. Binocular BCDVA

    Time frame: At Visit 2 Month 3

    Binocular BCDVA at 4 m under photopic conditions

Secondary outcomes

  1. Visual Acuity

    Time frame: Visit 2 Month 3

    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

  2. Visual Acuity

    Time frame: Visit 2 Month 3

    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

Sponsors and collaborators

Lead sponsor

Nvision Laser Eye Centers

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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