Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL (MonoeDOF)

A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract
• Intervention / Treatment: Procedure: Cataract surgery

Detailed Description

This study is aimed at patients who have a cloudy lens in both of their eyes, and are eligible for cataract surgery with implantation of an intraocular lens. Patients should be otherwise healthy with no other eye diseases.

The study will take place in 3 centers in Europe, including Oxford Eye Hospital, a part of Oxford University Hospitals NHS Trust and will include 70 patients in total.

The aim of the study is to investigate the safety and effectiveness of a new Intraocular Lens (IOL): the Monofocal Extended Depth of Focus (Mono-EDoF ME4) IOL and to compare it to a standard Monofocal IOL (TECNIS ZBC00). Patients participating will be randomised to either receive the Mono-EDoF ME4 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.

Total duration of clinical investigation is 12 months and the total expected duration for each patient is 8 months.

Patients will be screened for eligibility preoperatively obtaining a medical history and to establish a baseline ocular condition. Surgeries will be performed on different dates for both eyes but not more than one month apart. The patient will need to return to for seven follow-up visits after eye surgery where vision and health of the eye will be assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Cedex
    • Bordeaux, Cedex, France, 33076
      • University Hospital Pellegrin
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Oxford Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults 22 years of age and older at the time of consent.
2. Cataracts in both eyes.
3. Expected post-operative refractive astigmatism of ≤ 1.0 D.
4. Calculated lens power from 18 D to 30 D for both study IOLs.
5. Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months.
6. Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by phacoemulsification cataract extraction in both eyes.
7. Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery.
8. 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.
9. 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).
10. Pharmacologically dilated pupil size at least 6.0 mm.
11. 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).

Exclusion Criteria:

1. Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
2. Pregnancy or lactation.
3. 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).
4. Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
5. History of any intraocular or corneal surgery in either eye (including LASIK, PRK, etc.).
6. Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye.
7. 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.
8. Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
9. Any visually significant intraocular media opacity other than cataract in either eye.
10. 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.
11. History of cystoid macular edema in either eye.
12. Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements.
13. Uncontrolled (e.g., non-medicated) glaucoma in either eye.
14. Extremely shallow anterior chamber (< 2.0 mm).
15. Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes.
16. Irregular astigmatism, corneal degeneration or dystrophy.
17. Uncontrolled systemic disease (e.g., diabetes mellitus, active cancer treatment, mental illness, etc.) in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits.
18. Systemic medication that, in the opinion of the investigator, may confound the outcome or increase the intraoperative and post-operative risk to the subject (e.g., Tamsulosin Hydrochloride) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g., small pupil/floppy iris syndrome).
19. Subjects who may reasonably be expected to require any additional ophthalmic surgical intervention at any time during the study (other than YAG capsulotomy).
20. Need for concomitant procedures (e.g., glaucoma surgery, RK, LASIK, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Santen xact Mono-EDoF ME4 Intraocular Lens (IOL); 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; Small incision cataract surgery with implantation of an intraocular lens
Placebo Comparator: J&J TECNIS ZCB00 Intraocular Lens (IOL); 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; Small incision cataract surgery with implantation of an intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Distance Corrected Intermediate VA at Visit 4 (Month 3)	Subject's vision is corrected for distance and then subject's intermediate vision is measured using a 66-cm ETDRS chart.	80-100 days after second eye surgery
Monocular Uncorrected Intermediate VA at Visit 4 (Month 3)	Intermediate Visual Acuity is measured using a 66-cm ETDRS chart.	80-100 days after second eye surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoints	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by rates of adverse events.	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	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by loss of BCDVA.	Baseline, Visit 3 (Month 1), Visit 4 (Month 3), and Visit 5 (Month 6)
Safety endpoints	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by slit lamp examination.	Baseline, Visit 1 (Day 1), Visit 2 (Week 1), Visit 3 (Month 1), Visit 4 (Month 3), and Visit 5 (Month 6)
Safety endpoints	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by dilated fundus exam.	Baseline, Visit 5 (Month 6)
Safety endpoints	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by intraocular pressure.	Baseline, Visit 1 (Day 1), Visit 2 (Week 1), Visit 3 (Month 1), Visit 4 (Month 3), and Visit 5 (Month 6)
Safety endpoints	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by device deficiencies.	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	The primary safety endpoint is the overall safety profile of the study IOLs as reflected by visual symptoms.	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)

Collaborators and Investigators

• Sponsor: Advanced Vision Science, Inc.
• Investigators: Study Chair: Mark Packer, MD, Medical Monitor

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: AVS CP-7944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No