Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL)

Официальное название

BMVDI Study: Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus IOL

Обзор

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.

Вмешательства

• Устройство Clareon 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.

Первичные конечные точки

• 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 [Срок оценки: Baseline and 12 weeks after second eye surgery]

Вторичные конечные точки (4)

• Monocular and Binocular Best Distance Corrected Visual Acuity (BDCVA) [Срок оценки: Baseline and 12 weeks after second eye surgery]
• Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m, Uncorrected Intermediate Visual Acuity (UCIVA) at 66cm [Срок оценки: Baseline and 12 weeks after second eye surgery]
• Monocular DCIVA at 66cm [Срок оценки: Baseline and 12 weeks after second eye surgery]
• Monocular and Binocular distance corrected Defocus curve (at 3m) from +1.00D to -2.50D [Срок оценки: Baseline and 12 weeks after second eye surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Colvard-Kandavel Eye Center — Encino

Публикации

• 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.
• 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. PMID 41164804
• Blehm C. Visual Acuity Using a Defocus Curve and Refractive Stability in the Alcon Clareon IOL.
• 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. PMID 38146452
• 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. PMID 37085852
• 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. PMID 37621091
• 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).
• 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).

Идентификаторы

NCT: NCT07589894 · BMVDI-102745323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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