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

NCT07768475 | Active Not Recruiting FDA Device

• 1 other identifier: NVision Zhu Head to Head IIT
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cataracts

Keywords

Cataracts; PanOptix; Odyssey

Outcome Measures

Primary Outcomes (1)

• Binocular BCDVA

  Binocular BCDVA at 4 m under photopic conditions

  At Visit 2 Month 3

Secondary Outcomes (2)

• Visual Acuity

  Visit 2 Month 3

• Visual Acuity

  Visit 2 Month 3

Study Arms (2)

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

ACTIVE COMPARATOR

One of 2 IOLs being used in the study

Device: Intraocular Lens Implant

Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225

ACTIVE COMPARATOR

One of 2 IOLs being used in the study

Device: Intraocular Lens Implant

Interventions

Intraocular Lens Implant DEVICE

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nvision Laser Eye Centers: lead

Study Sites (4)

Hyperspeed LASIK

Rowland Heights, California, 91748, United States

Location

Seeta Eye Center

Poughkeepsie, New York, 12603, United States

Location

Texas Eye and Laser Center

Hurst, Texas, 76054, United States

Location

Parkhurst Nuvision

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: July 7, 2025
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-07

Locations

US (4)