Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

NCT04631068 | Completed

• 1 other identifier: AVS CP-7944
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 3

Brief Summary

Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens. Primary Objectives:

• To evaluate the distance VA of the study IOLs
• To evaluate the intermediate VA of the study IOLs
• To explore the safety profile with regards to visual disturbances

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Monocular Uncorrected Distance VA at Visit 4 (Month 3)

  Monocular uncorrected distance visual acuity measured using ETDRS visual acuity chart

  80-100 days after second eye surgery

Secondary Outcomes (2)

• Monocular Distance Corrected Intermediate VA at Visit 4 (Month 3)

  80-100 days after second eye surgery

• Monocular Uncorrected Intermediate VA at Visit 4 (Month 3)

  80-100 days after second eye surgery

Other Outcomes (7)

• Safety endpoints

  Baseline, Day 0 (Surgery), Visit 1 (Day 1), Visit 2 (Week 1), Visit 3 (Month 1), Visit 4 (Month 3), and Visit 5 (Month 6)

• Safety endpoints

  Baseline, Visit 3 (Month 1), Visit 4 (Month 3), and Visit 5 (Month 6)

• Safety endpoints

  Baseline, Visit 1 (Day 1), Visit 2 (Week 1), Visit 3 (Month 1), Visit 4 (Month 3), and Visit 5 (Month 6)

Study Arms (2)

Santen xact Mono-EDoF ME4 Intraocular Lens (IOL)

ACTIVE COMPARATOR

The Monofocal Extended Depth of Focus (Mono-EDoF) posterior chamber foldable intraocular lens is ultraviolet and blue-light absorbing designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. The diffractive technology of the IOL allows most of the light to converge in one focal point thereby providing high quality of distance vision and continuous focus to intermediate vision while minimizing the effects of unwanted visual disturbances. The visual quality is expected to be similar to monofocal IOLs. Surgery to implant the Mono-EDoF ME4 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification.

Procedure: Cataract surgery

J&J TECNIS ZCB00 Intraocular Lens (IOL)

PLACEBO COMPARATOR

The TECNIS 1-Piece Intraocular Lens (IOL), Model ZCB00, is a standard monofocal ultraviolet light absorbing posterior chamber IOL, which is designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. Surgery to implant the TECNIS ZCB00 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification.

Procedure: Cataract surgery

Interventions

Cataract surgery PROCEDURE

Small incision cataract surgery with implantation of an intraocular lens

J&J TECNIS ZCB00 Intraocular Lens (IOL); Santen xact Mono-EDoF ME4 Intraocular Lens (IOL)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 22 years of age and older at the time of consent.
• Cataracts in both eyes.
• Expected post-operative refractive astigmatism of ≤ 1.0 D.
• Calculated lens power from 18 D to 30 D for both study IOLs.
• Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months.
• Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by phacoemulsification cataract extraction in both eyes.
• Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery.
• Preoperative best corrected distance visual acuity (BCDVA) of 20/32 or worse, with or without a glare source, or preoperative BCDVA of 20/25 or worse with patient complaining of severe visual disturbances attributable to cataract.
• Post-operative BCVA projected to be 0.2 LogMAR or better (as determined by the medical judgment of the Investigator or measured by potential acuity meter / retinal acuity meter (PAM / RAM) if necessary).
• Pharmacologically dilated pupil size at least 6.0 mm.
• Must be able to understand and provide informed consent themselves or through a representative with a witness present on the IRB or EC approved Informed Consent Form (ICF).

You may not qualify if:

• Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
• Pregnancy or lactation.
• Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms - CRF's).
• History of any intraocular or corneal surgery in either eye (including LASIK, PRK, etc.).
• Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye.
• Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis, aniridia, rubeosis iridis, clinically significant corneal disease, Fuchs, or anterior membrane dystrophies, etc.) in either eye.
• Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
• Any visually significant intraocular media opacity other than cataract in either eye.
• History of any clinically significant retinal pathology or ocular diagnosis (e.g., diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, amblyopia, optic neuropathy, microphthalmos, aniridia, etc.) in either eye that could alter or limit final postoperative visual prognosis.
• History of cystoid macular edema in either eye.
• Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements.
• Uncontrolled (e.g., non-medicated) glaucoma in either eye.
• Extremely shallow anterior chamber (\< 2.0 mm).
• Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes.
• Irregular astigmatism, corneal degeneration or dystrophy.

Sponsors & Collaborators

• Advanced Vision Science, Inc.: lead

Study Sites (3)

University Hospital Pellegrin

Bordeaux, Cedex, 33076, France

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Oxford Eye Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (18)

• Black S. Successful Restoration of Visual Acuity with an Extended Range of Vision Intraocular Lens after Multifocal Laser Ablation. Case Rep Ophthalmol. 2016 Oct 11;7(3):193-197. doi: 10.1159/000450675. eCollection 2016 Sep-Dec.

  PMID: 28101037 BACKGROUND

• Bostanci Ceran B, Takmaz T, Can I, Demirok G, Uysal BS. Clinical outcomes and optical performance of four differentmultifocal intraocular lenses. Turk J Med Sci. 2016 Apr 19;46(3):597-603. doi: 10.3906/sag-1403-24.

  PMID: 27513232 BACKGROUND

• Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16. doi: 10.1016/j.ophtha.2008.04.017. Epub 2008 Jun 5.

  PMID: 18538402 BACKGROUND

• Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. doi: 10.1016/j.jcrs.2016.06.033.

  PMID: 27697244 BACKGROUND

• Davison JA, Simpson MJ. History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg. 2006 May;32(5):849-58. doi: 10.1016/j.jcrs.2006.02.006.

  PMID: 16765805 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

• Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.e2. doi: 10.1016/j.ophtha.2007.08.042. Epub 2007 Nov 26.

  PMID: 18031818 BACKGROUND

• Hashemi H, Khabazkhoob M, Soroush S, Shariati R, Miraftab M, Yekta A. The location of incision in cataract surgery and its impact on induced astigmatism. Curr Opin Ophthalmol. 2016 Jan;27(1):58-64. doi: 10.1097/ICU.0000000000000223.

  PMID: 26569524 BACKGROUND

• Kaymak H, Hohn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.

  PMID: 27385257 BACKGROUND

• Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual performance with accommodating and multifocal intraocular lenses. Int J Ophthalmol. 2017 Feb 18;10(2):235-240. doi: 10.18240/ijo.2017.02.09. eCollection 2017.

  PMID: 28251082 BACKGROUND

• Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.

  PMID: 27400074 BACKGROUND

• Prasher P, Sandhu JS. Prevalence of corneal astigmatism before cataract surgery in Indian population. Int Ophthalmol. 2017 Jun;37(3):683-689. doi: 10.1007/s10792-016-0327-z. Epub 2016 Aug 27.

  PMID: 27567924 BACKGROUND

• TECNIS Symfony DFU

  BACKGROUND

• Ruiz-Mesa R, Abengozar-Vela A, Aramburu A, Ruiz-Santos M. Comparison of visual outcomes after bilateral implantation of extended range of vision and trifocal intraocular lenses. Eur J Ophthalmol. 2017 Jun 26;27(4):460-465. doi: 10.5301/ejo.5000935. Epub 2017 Jan 28.

  PMID: 28165609 BACKGROUND

• Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.

  PMID: 26796456 BACKGROUND

• Attia MSA, Auffarth GU, Kretz FTA, Tandogan T, Rabsilber TM, Holzer MP, Khoramnia R. Clinical Evaluation of an Extended Depth of Focus Intraocular Lens With the Salzburg Reading Desk. J Refract Surg. 2017 Oct 1;33(10):664-669. doi: 10.3928/1081597X-20170621-08.

  PMID: 28991333 RESULT

• Bellucci R. Multifocal intraocular lenses. Curr Opin Ophthalmol. 2005 Feb;16(1):33-7. doi: 10.1097/00055735-200502000-00006.

  PMID: 15650577 RESULT

• Packer M, Monteiro T, Schweitzer C, Rosen P. Prospective, randomized, controlled multicenter study of a monofocal EDOF intraocular lens compared with a standard aspheric monofocal intraocular lens. J Cataract Refract Surg. 2025 Aug 1;51(8):659-665. doi: 10.1097/j.jcrs.0000000000001672.

  PMID: 40245412 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mark Packer, MD

  Medical Monitor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients participating will be randomised to either receive the Mono-EDoF ME4 Intraocular Lens (IOL) in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL. Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses.

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 17, 2020
• Study Start: September 21, 2020
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (1); PT (1)