Cataract, Cataract Bilateral, Cataract (Post-operative Cataract Surgery Follow-up), Cataract Surgery
Conditions
Brief summary
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular lens (IOL). Clareon TruPlus IOL is designed to provide an extended range of vision compared to the parent monofocal IOL. Clareon TruPlus IOL delivers excellent intermediate vision without compromising distance vision including the quality of vision with low incidence of visual disturbances in normal cataract patients. Binocular distance-corrected intermediate visual acuity at 66cm will be assessed at a pre-specified postoperative interval 12 weeks after second eye surgery. This study hypothesizes that Clareon TruPlus IOL delivers good binocular DCIVA at 66cm 12 weeks after second eye surgery.
Interventions
DEVICEClareon TruPlus IOL
A prospective, single-site, observational study evaluating binocular and monocular distance-corrected and uncorrected visual performance following bilateral implantation of the TruPlus intraocular lens (IOL). Both eyes will be targeted for emmetropia using Argos biometry with IOL power calculated by the Barrett Universal formula. Second-eye surgery will occur within 2 weeks of the first eye. Final evaluation will take place 12 weeks after second eye surgery.
Sponsors
Colvard Kandavel Eye Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to understand and sign informed consent. * Able and willing to complete all required study visits. * Diagnosed with age-related cataracts in both eyes (OU) * Bilateral age-related cataract scheduled for phacoemulsification in both eyes by a single surgeon. * Surgeon predicts postoperative best corrected distance visual acuity (BCDVA) of ≥ 20/25 or better with Manifest Refractive Spherical Equivalent (MRSE) ±0.50 D of plano and in each eye post-operatively. * Clear intraocular media aside from cataract. * Will receive TruPlus bilaterally * Postoperative residual astigmatism ≤ 0.75 D in both eyes. * Refractive target: Emmetropia OU * Patient groups agreeing to either Femtosecond Laser Assisted Cataract Surgery (FLACS) or Standard phaco
Exclusion criteria
* Ocular comorbidities affecting visual outcomes, including but not limited to: * Macular disease (e.g., Age-Related Macular Degeneration \[AMD\], Diabetic Macular Edema \[DME\], Epiretinal Membrane \[ERM\]). * Active ocular inflammation. * Any investigator-determined condition likely to confound postoperative visual performance. * Strabismus with or without amblyopia in either eye. * Prior anterior or posterior segment surgery, including corneal refractive procedures. * History of retinal detachment. * Degenerative retinal or visual disorders deemed clinically significant by the investigator. * Diagnosed glaucoma (of any stage, if deemed vision-impacting by investigator). * Systemic conditions that could affect healing or study outcomes (e.g., immunocompromised, connective tissue disease, clinically significant atopy, diabetes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular distance-corrected intermediate visual acuity (DCIVA) and Logarithm of the Minimum Angle of Resolution (logMAR) at 66cm at 12 weeks after second eye surgery | Baseline and 12 weeks after second eye surgery |
Secondary
| Measure | Time frame |
|---|---|
| Monocular and Binocular Best Distance Corrected Visual Acuity (BDCVA) | Baseline and 12 weeks after second eye surgery |
| Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m, Uncorrected Intermediate Visual Acuity (UCIVA) at 66cm | Baseline and 12 weeks after second eye surgery |
| Monocular DCIVA at 66cm | Baseline and 12 weeks after second eye surgery |
| Monocular and Binocular distance corrected Defocus curve (at 3m) from +1.00D to -2.50D | Baseline and 12 weeks after second eye surgery |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGanesha R Kandavel, MD
Coilvard-Kandavel Eye Center
Outcome results
None listed