Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon TruPlus IOL | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Colvard-Kandavel Eye Center patients with bilateral cataracts
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ganesha R Kandavel, MD | Coilvard-Kandavel Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colvard-Kandavel Eye Center | Encino | California | 91316 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Srinivasan S et al. Meta-analysis of Defocus Curves of Monofocal, Enhanced Monofocal, and EDoF IOLs. Giglio R, Tognetto D. Evaluation of an Enhanced Monofocal IOL Compared to Clareon Monofocal and Tecnis 1-Piece. | ||
| 41164804 | Background | Tran E, Shah N, Caballero Ortiz S, Kyveris A, Berg G, Chan T. Visual Performance and Refractive Stability of Clareon(R) Monofocal Intraocular Lens Implanted with an Automated Delivery System. Clin Ophthalmol. 2025 Oct 24;19:3933-3939. doi: 10.2147/OPTH.S545977. eCollection 2025. | |
| Background | Blehm C. Visual Acuity Using a Defocus Curve and Refractive Stability in the Alcon Clareon IOL. | ||
| 38146452 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Background |
| Micheletti JM, Duncan NB, Hall B. Head-to-Head Comparison of Intermediate Vision of Two Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Dec 21;17:3983-3990. doi: 10.2147/OPTH.S444696. eCollection 2023. |
| 37085852 | Background | Beltraminelli T, Rizzato A, Toniolo K, Galli A, Menghini M. Comparison of visual performances of enhanced monofocal versus standard monofocal IOLs in a mini-monovision approach. BMC Ophthalmol. 2023 Apr 21;23(1):170. doi: 10.1186/s12886-023-02920-6. |
| 37621091 | Background | Park MJ, Lee HS, Chang IB, Hong IH. Improved Intermediate Visual Function with New Monofocal Intraocular Lens in Combined Cataract and Vitrectomy Surgery for Retinal Disease. Korean J Ophthalmol. 2023 Oct;37(5):401-408. doi: 10.3341/kjo.2023.0056. Epub 2023 Aug 25. |
| Background | Garzón, N., et al. Visual and optical quality of enhanced intermediate monofocal intraocular lenses. International Journal of Ophthalmology. 2022; 15(9): (description of the Tecnis® Eyhance ICB00 as having modified aspheric optics and improved intermediate vision with preserved distance visual acuity). |
| Background | Auffarth, G. U., et al. Clinical evaluation of a new monofocal intraocular lens with enhanced intermediate function in cataract patients. Journal of Cataract & Refractive Surgery. 2021; 47(2): (results showing improved intermediate vision with Tecnis Eyhance and comparable distance outcomes). |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided