Visual Outcomes and Quality of Life After Vivity EDOF IOL Implantation in Early-Stage Keratoconus

NCT07338708 | Completed

• 1 other identifier: prot. n. 22546
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the Vivity Extended Depth of Focus intraocular lens works to improve vision in adults with cataracts and early-stage keratoconus. It will also learn about the safety and tolerance of this premium lens in patients with mild corneal irregularities. The main questions it aims to answer are:

• Does the Vivity EDOF lens provide good distance vision (20/25 or better) in the dominant eye at 3 months after surgery?
• Does it improve vision at intermediate and near distances compared to before surgery?
• Does it preserve contrast sensitivity and optical quality despite mild corneal irregularities?
• What is the patient-reported quality of life and satisfaction after implantation?
• What visual disturbances (such as halos) do participants experience? All participants will:
• Receive the Vivity EDOF intraocular lens (or its toric version if astigmatism is present) in both eyes during standard cataract surgery, with the second eye operated within 7 days;
• Undergo comprehensive eye examinations before surgery including vision testing, corneal imaging, and optical quality measurements;
• Attend a follow-up visit at 3 months after surgery for detailed vision testing at multiple distances, contrast sensitivity testing under different lighting conditions, halo assessment, and quality-of-life questionnaires.

Conditions

Cataract; Keratoconic Subjects

Keywords

EDOF IOL; Cataract; Vivity IOL; Early keratoconous; spectacle independence; optical quality; quality of life

Outcome Measures

Primary Outcomes (1)

• Distance-Corrected Visual Acuity in the Dominant Eye

  Monocular distance-corrected visual acuity (DCVA) measured in the dominant eye at 4 meters using CSO Vision Charts software version 14.0, recorded in logMAR units. Lower logMAR values indicate better visual acuity (e.g., 0.0 logMAR = Snellen 20/20; 0.1 logMAR = Snellen 20/25). Visual acuity is measured with best spectacle correction to assess the maximum visual performance achievable with the implanted IOL. The target outcome is DCVA of 0.1 logMAR (20/25) or better, indicating clinically excellent visual function. This primary endpoint evaluates whether the Vivity EDOF IOL can maintain high-quality distance vision despite the presence of mild corneal irregularities characteristic of early keratoconus

  3 months after surgery

Secondary Outcomes (11)

• Monocular and Binocular Uncorrected Distance Visual Acuity

  Baseline (preoperative) and 3 months after surgery

• Monocular and Binocular Uncorrected and Distance-Corrected Near Visual Acuity

  Baseline (preoperative) and 3 months after surgery

• Monocular and Binocular Uncorrected and Distance-Corrected Intermediate Visual Acuity

  3 months after surgery

• Binocular Defocus Curve Visual Acuity Profile

  3 months after surgery

• Monocular and Binocular Contrast Sensitivity Under Photopic, Mesopic, and Scotopic Conditions

  3 months after surgery

Study Arms (1)

Vivity EDOF IOL in Early Keratoconus

EXPERIMENTAL

Adults with cataracts and mild, stable bilateral keratoconus (ABCD stage 0-1) undergo bilateral implantation of the AcrySof IQ Vivity Extended Depth of Focus (EDOF) intraocular lens during standard phacoemulsification cataract surgery. The toric version is used in eyes with regular corneal astigmatism ≥1.00 D. Surgery is performed under topical anesthesia by the same surgeon, targeting bilateral emmetropia using Kane formula for IOL power calculation. The second eye is operated within 7 days of the first. The Vivity IOL is a non-diffractive EDOF lens utilizing X-WAVE wavefront-shaping technology to extend focal range without splitting light, designed to reduce visual disturbances while providing functional vision at distance, intermediate (66 cm), and near (40 cm). Comprehensive visual, optical quality, contrast sensitivity, and patient-reported outcomes are assessed at 3 months postoperatively

Device: Extended Depth of Focus Intraocular Lens Implantation

Interventions

Extended Depth of Focus Intraocular Lens Implantation DEVICE

Bilateral implantation of the AcrySof IQ Vivity (Alcon, Fort Worth, TX, USA) Extended Depth of Focus (EDOF) intraocular lens during phacoemulsification cataract surgery. The Vivity is a single-piece hydrophobic acrylic IOL (6.0 mm optic, 13.0 mm overall length) featuring non-diffractive X-WAVE wavefront-shaping technology with a slightly elevated central plateau (\~1 µm) and surrounding curvature modulation to extend focal range. It incorporates UV and blue light filtering with refractive index 1.55 at 35°C. The spherical model (powers +15.0 D to +25.0 D) or toric model (cylinder 1.03 D to 4.11 D at IOL plane) is selected based on corneal astigmatism. IOL power calculated using Kane formula targeting emmetropia. Surgery performed with 2.2 mm incision under topical anesthesia, with second-eye surgery within 7 days. This study specifically evaluates performance in patients with early-stage stable keratoconus.

Vivity EDOF IOL in Early Keratoconus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults requiring bilateral cataract surgery
• Mild bilateral keratoconus defined as stage 0-1 according to the ABCD classification system
• Keratoconus stability defined as maximum keratometry (K) changes less than 1 diopter and maximum pachymetry reduction less than 2% within the previous 5 years
• Pre-cataract spectacle distance-corrected visual acuity of 0.1 to 0.0 LogMAR (Snellen 20/25 to 20/20)
• Agreement to bilateral implantation of AcrySof IQ Vivity Extended Depth of Focus intraocular lens
• Willingness to undergo second-eye surgery within 7 days after first-eye procedure
• Ability and willingness to attend all scheduled follow-up visits as per study protocol
• Provision of written informed consent to participate in the study

You may not qualify if:

• Any ocular comorbidities other than cataract and keratoconus, or history of any disease that could affect visual results (e.g., glaucoma, retinal disorders)
• Corneal opacity including any corneal scarring
• Advanced or progressive keratoconus
• Any previous ocular surgery other than corneal cross-linking performed at least 5 years prior to enrollment
• Corneal cross-linking performed within 5 years prior to enrollment
• Amblyopia
• Pseudoexfoliation syndrome or zonular laxity
• History of uveitis

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Integrata di Verona

Verona, Verona, 37134, Italy

Location

Related Publications (14)

• Farideh D, Azad S, Feizollah N, Sana N, Cyrus A, Mohammad G, Alireza BR. Clinical outcomes of new toric trifocal diffractive intraocular lens in patients with cataract and stable keratoconus: Six months follow-up. Medicine (Baltimore). 2017 Mar;96(12):e6340. doi: 10.1097/MD.0000000000006340.

  PMID: 28328814 BACKGROUND

• Rampat R, Gatinel D. Multifocal and Extended Depth-of-Focus Intraocular Lenses in 2020. Ophthalmology. 2021 Nov;128(11):e164-e185. doi: 10.1016/j.ophtha.2020.09.026. Epub 2020 Sep 25.

  PMID: 32980397 BACKGROUND

• Pedrotti E, Chierego C, Talli PM, Selvi F, Galzignato A, Neri E, Barosco G, Montresor A, Rodella A, Marchini G. Extended Depth of Focus Versus Monofocal IOLs: Objective and Subjective Visual Outcomes. J Refract Surg. 2020 Apr 1;36(4):214-222. doi: 10.3928/1081597X-20200212-01.

  PMID: 32267951 BACKGROUND

• Palomino-Bautista C, Sanchez-Jean R, Carmona-Gonzalez D, Pinero DP, Molina-Martin A. Subjective and objective depth of field measures in pseudophakic eyes: comparison between extended depth of focus, trifocal and bifocal intraocular lenses. Int Ophthalmol. 2020 Feb;40(2):351-359. doi: 10.1007/s10792-019-01186-6. Epub 2019 Oct 3.

  PMID: 31583551 BACKGROUND

• Gillmann K, Mermoud A. Visual Performance, Subjective Satisfaction and Quality of Life Effect of a New Refractive Intraocular Lens with Central Extended Depth of Focus. Klin Monbl Augenheilkd. 2019 Apr;236(4):384-390. doi: 10.1055/a-0799-9700. Epub 2019 Feb 14.

  PMID: 30763956 BACKGROUND

• Pedrotti E, Mastropasqua R, Passilongo M, Parisi G, Marchesoni I, Marchini G. Comparison of two multifocal intraocular lens designs that differ only in near add. J Refract Surg. 2014 Nov;30(11):754-60. doi: 10.3928/1081597X-20141021-07.

  PMID: 25375848 BACKGROUND

• Alio JL, Pinero DP, Plaza-Puche AB, Amparo F, Jimenez R, Rodriguez-Prats JL, Javaloy J. Visual and optical performance with two different diffractive multifocal intraocular lenses compared to a monofocal lens. J Refract Surg. 2011 Aug;27(8):570-81. doi: 10.3928/1081597X-20101223-01. Epub 2011 Jan 3.

  PMID: 21210572 BACKGROUND

• Gil MA, Varon C, Cardona G, Vega F, Buil JA. Comparison of far and near contrast sensitivity in patients symmetrically implanted with multifocal and monofocal IOLs. Eur J Ophthalmol. 2014 Jan-Feb;24(1):44-52. doi: 10.5301/ejo.5000335. Epub 2013 Jun 24.

  PMID: 23813113 BACKGROUND

• Buckhurst PJ, Naroo SA, Davies LN, Shah S, Drew T, Wolffsohn JS. Assessment of dysphotopsia in pseudophakic subjects with multifocal intraocular lenses. BMJ Open Ophthalmol. 2017 Jun 19;1(1):e000064. doi: 10.1136/bmjophth-2016-000064. eCollection 2017.

  PMID: 29354708 BACKGROUND

• de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.

  PMID: 27943250 BACKGROUND

• Flockerzi E, Vinciguerra R, Belin MW, Vinciguerra P, Ambrosio R Jr, Seitz B. Combined biomechanical and tomographic keratoconus staging: Adding a biomechanical parameter to the ABCD keratoconus staging system. Acta Ophthalmol. 2022 Aug;100(5):e1135-e1142. doi: 10.1111/aos.15044. Epub 2021 Oct 16.

  PMID: 34655452 BACKGROUND

• Vandevenne MMS, Webers VSC, Segers MHM, Berendschot TTJM, Zadok D, Dickman MM, Nuijts RMMA, Abulafia A. Accuracy of intraocular lens calculations in eyes with keratoconus. J Cataract Refract Surg. 2023 Mar 1;49(3):229-233. doi: 10.1097/j.jcrs.0000000000001088. Epub 2022 Oct 28.

  PMID: 36314969 BACKGROUND

• Haigis W. Challenges and approaches in modern biometry and IOL calculation. Saudi J Ophthalmol. 2012 Jan;26(1):7-12. doi: 10.1016/j.sjopt.2011.11.007.

  PMID: 23960962 BACKGROUND

• Hashemi H, Heydarian S, Hooshmand E, Saatchi M, Yekta A, Aghamirsalim M, Valadkhan M, Mortazavi M, Hashemi A, Khabazkhoob M. The Prevalence and Risk Factors for Keratoconus: A Systematic Review and Meta-Analysis. Cornea. 2020 Feb;39(2):263-270. doi: 10.1097/ICO.0000000000002150.

  PMID: 31498247 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Ophthalmology

Model Details: This is a single-arm, prospective pilot study evaluating bilateral implantation of the AcrySof IQ Vivity Extended Depth of Focus (EDOF) intraocular lens (IOL) in patients with cataracts and early-stage, stable keratoconus. All participants receive the same intervention (Vivity EDOF IOL in both eyes, or its toric version if corneal astigmatism ≥1.00 D is present), with surgery on the second eye performed within 7 days of the first. There is no control or comparison group. The study explores whether this non-diffractive EDOF technology, which uses wavefront-shaping to extend focal range while preserving contrast sensitivity, can safely provide functional vision at multiple distances in a population (early keratoconus) traditionally considered unsuitable for premium IOLs due to corneal irregularities and higher-order aberrations. Outcomes are assessed at 3 months postoperatively.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: September 17, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)