Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

Cataract Clinical Trial

— MonoeDOF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631068
• Other study ID #: AVS CP-7944
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: March 17, 2023

Study information

• Verified date: June 2024
• Source: Advanced Vision Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• Cataract surgery
Small incision cataract surgery with implantation of an intraocular lens

Locations

Country	Name	City	State
France	University Hospital Pellegrin	Bordeaux	Cedex
Portugal	Hospital de Braga	Braga
United Kingdom	Oxford Eye Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Vision Science, Inc.

Countries where clinical trial is conducted

France,  Portugal,  United Kingdom, 

References & Publications (17)

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-201706 — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

TECNIS Symfony DFU

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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
Secondary	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