Cataracts
Conditions
Keywords
Cataracts, PanOptix, Odyssey
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
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)
Interventions
DEVICEIntraocular Lens Implant
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 \& 4 (BLF)
Sponsors
Nvision Laser Eye Centers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Willing and able to understand and sign informed consent 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
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, autoimmune 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular BCDVA | At Visit 2 Month 3 | Binocular BCDVA at 4 m under photopic conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 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 |
Countries
United States
Outcome results
None listed