A Prospective Study Comparing Visual Outcomes and Patient Satisfaction Following Implantation of the Clareon PanOptix Versus Tecnis Odyssey IOL in Patients Undergoing Cataract Surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Rowland Heights, California, United States, 91748
- Hyperspeed LASIK
-
-
New York
-
Poughkeepsie, New York, United States, 12603
- Seeta Eye center
-
-
Texas
-
Hurst, Texas, United States, 76054
- Texas Eye and Laser Center
-
San Antonio, Texas, United States, 78229
- Parkhurst NuVision
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)
One of 2 IOLs being used in the study
|
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)
Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225
|
|
Active Comparator: Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225
One of 2 IOLs being used in the study
|
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)
Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Binocular BCDVA
Time Frame: At Visit 2 Month 3
|
Binocular BCDVA at 4 m under photopic conditions
|
At Visit 2 Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Visit 2 Month 3
|
|
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
|
Visit 2 Month 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NVision Zhu Head to Head IIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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