Evaluation of Visual Function After Bilateral Implantation of EDOF IOLs

NCT05335408 | Completed

• 1 other identifier: NL79042.068.21
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Since intermediate vision is becoming increasingly important in our day-to-day tasks, a new IOL was introduced (Acunex Vario) with this objective in mind. This IOL provides excellent vision at far and intermediate distances up to 60 cm and with negligible photopic disturbances compared to conventional multifocal lenses. The Alcon AcrySof IQ Vivity IOL is designed to provide continuous vision from distance to intermediate while preserving contrast sensitivity and with a monofocal visual disturbance profile. So far, there are no published studies comparing these new IOL designs that offer an extended range of vision at far and intermediate distances. Objective: The primary objective of this study is to compare the binocular uncorrected intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Vario IOL versus those bilaterally implanted with the Vivity IOL. Study design: controlled double masked, randomized, prospective clinical trial Study population: patients of 18 years or older with bilateral cataracts that require cataract surgery. Intervention: One group receives bilateral implantation with the Vario IOL and the other group receives bilateral implantation with the Vivity IOL. Main study parameters: The main study parameter is the binocular UIVA at 66 cm under photopic conditions at 3 months postoperatively. Hypothesis: The investigators hypothesise that bilateral implantation with the Vario IOL is non-inferior when compared to bilateral implantation with the Vivity IOL, with regards to binocular UIVA at 66 cm under photopic conditions 3 months postoperatively. Cataract extraction in this study will proceed according to regular cataract surgery. As with any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug reactions, and surgical problems. Postoperatively, there will be one extra postoperative visit, compared to standard cataract surgery follow-up. Spectacle-independency postoperatively, without photopic phenomena, is one of the major expected benefits when treating cataract (and presbyopia) with the implantation of the Vario or Vivity IOLs.

Conditions

Cataract Bilateral; Lens, Intraocular; Lens Implantation, Intraocular; Pseudophakia; Visual Acuity

Keywords

Extended depth of Focus intraocular lenses; Intermermediate visual acuity

Outcome Measures

Primary Outcomes (1)

• Binocular uncorrected intermediate visual acuity

  The visual acuity will be measured at 66cm under photopic conditions

  3 months postoperatively

Secondary Outcomes (12)

• Mono- and binocular uncorrected and corrected distance visual acuity

  At week 1, 1 month and 3 months postoperatively

• Mean binocular distance-corrected intermediate visual acuity

  At 1 and 3 months postoperatively

• Mean binocular uncorrected near visual acuity and distaqnce corrected near visual acuity

  At 1 and 3 months postoperatively

• Binocular defocus curves

  At 3 months postoperatively

• Mean binocular constrast sensitivity

  At 3 months postoperatively

Study Arms (2)

Vario-group

EXPERIMENTAL

Patients in this group recieve the Acunex Vario IOL bilaterally during the cataract surgery.

Device: Acunex Vario intraocular lens

Vivity-group

ACTIVE COMPARATOR

Patients in this group recieve the Alcon Acrysof IQ Vivity IOL bilaterally during the cataract surgery.

Device: Alcon AcrySof IQ Vivity intraocular lens

Interventions

Acunex Vario intraocular lens DEVICE

This is an extended depth of focus IOL, made by Teleon Surgical B.V.

Vario-group

Alcon AcrySof IQ Vivity intraocular lens DEVICE

This is an extended depth of focus IOL, made by Alcon.

Vivity-group

Eligibility Criteria

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

You may qualify if:

• Minimum 18 years of age
• Bilateral cataract
• Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ Vivity® IOL
• Expected postoperative astigmatism ≤ 1.00 D (use of femtosecond laser assisted cataract surgery (FLACS) AK's tolerated up to 1.5 D of corneal astigmatism preoperative)
• Bilateral implantation of a non-toric Acunex® Vario IOL or a non-toric Alcon AcrySof® IQ Vivity® IOL
• IOL power calculation between +10.00 D and +30.0 D
• Expected postoperative best-corrected visual acuity of logMAR 0.3 or better
• Availability to undergo second eye surgery on the same day or else within 2 weeks of the first eye surgery
• Willing and able to comply with scheduled visits and other study procedures
• Signed informed consent

You may not qualify if:

• Previous corneal surgery and/or reshaping
• Corneal pathology (i.e., fuchs endothelial dystrophy (FED), irregular astigmatism, herpes simplex virus (HSV) keratitis
• Extensive age-related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen) and post-intravitreal injection (IVI)
• Extensive visual field loss (eg. glaucoma, cerebral vascular accident (CVA), hemianopsia, etc.)
• Extensive diabetic retinopathy
• Amblyopia, strabismus, diplopia
• Pseudo exfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic /scotopic conditions)
• Cognitive cerebral or concentration disorders (e.g., dementia, Parkinson, stroke, etc.)
• Suturing of incision required at time of surgery
• Complications during surgery of the first eye.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (10)

• Breyer DRH, Kaymak H, Ax T, Kretz FTA, Auffarth GU, Hagen PR. Multifocal Intraocular Lenses and Extended Depth of Focus Intraocular Lenses. Asia Pac J Ophthalmol (Phila). 2017 Jul-Aug;6(4):339-349. doi: 10.22608/APO.2017186.

  PMID: 28780781 BACKGROUND

• Jonker SM, Bauer NJ, Makhotkina NY, Berendschot TT, van den Biggelaar FJ, Nuijts RM. Comparison of a trifocal intraocular lens with a +3.0 D bifocal IOL: results of a prospective randomized clinical trial. J Cataract Refract Surg. 2015 Aug;41(8):1631-40. doi: 10.1016/j.jcrs.2015.08.011.

  PMID: 26432120 BACKGROUND

• de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.

  PMID: 23332253 BACKGROUND

• Vrijman V, van der Linden JW, van der Meulen IJE, Mourits MP, Lapid-Gortzak R. Multifocal intraocular lens implantation after previous corneal refractive laser surgery for myopia. J Cataract Refract Surg. 2017 Jul;43(7):909-914. doi: 10.1016/j.jcrs.2017.06.028.

  PMID: 28823437 BACKGROUND

• Liu J, Dong Y, Wang Y. Efficacy and safety of extended depth of focus intraocular lenses in cataract surgery: a systematic review and meta-analysis. BMC Ophthalmol. 2019 Sep 2;19(1):198. doi: 10.1186/s12886-019-1204-0.

  PMID: 31477053 BACKGROUND

• Kohnen T, Suryakumar R. Extended depth-of-focus technology in intraocular lenses. J Cataract Refract Surg. 2020 Feb;46(2):298-304. doi: 10.1097/j.jcrs.0000000000000109.

  PMID: 32126045 BACKGROUND

• Webers VSC, Bauer NJC, Saelens IEY, Creten OJM, Berendschot TTJM, van den Biggelaar FJHM, Nuijts RMMA. Comparison of the intermediate distance of a trifocal IOL with an extended depth-of-focus IOL: results of a prospective randomized trial. J Cataract Refract Surg. 2020 Feb;46(2):193-203. doi: 10.1097/j.jcrs.0000000000000012.

  PMID: 32126031 BACKGROUND

• Alio JL, Plaza-Puche AB, Fernandez-Buenaga R, Pikkel J, Maldonado M. Multifocal intraocular lenses: An overview. Surv Ophthalmol. 2017 Sep-Oct;62(5):611-634. doi: 10.1016/j.survophthal.2017.03.005. Epub 2017 Mar 31.

  PMID: 28366683 BACKGROUND

• Erie JC, Simpson MJ, Bandhauer MH. A modified intraocular lens design to reduce negative dysphotopsia. J Cataract Refract Surg. 2019 Jul;45(7):1013-1019. doi: 10.1016/j.jcrs.2019.01.019. Epub 2019 Apr 16.

  PMID: 31003799 BACKGROUND

• Ferreira TB, Ribeiro FJ. Prospective Comparison of Clinical Performance and Subjective Outcomes Between Two Diffractive Trifocal Intraocular Lenses in Bilateral Cataract Surgery. J Refract Surg. 2019 Jul 1;35(7):418-425. doi: 10.3928/1081597X-20190528-02.

  PMID: 31298721 BACKGROUND

MeSH Terms

Conditions

Cataract; Pseudophakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudy Nuijts, MD, PhD

  University Eye Clinic Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study optometrists (who will perform the examinations)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a single-center, double masked, prospective randomized clinical study. The study will be conducted at the University Eye Clinic Maastricht of the Maastricht University Medical Centre+ (MUMC+) in the Netherlands. The study consists of two study groups: Vario-group (implantation with the Acunex® Vario IOL) and the Vivity-group (implantation with the Alcon AcrySof® IQ Vivity® IOL). A total of 32 patients will be randomized into either the Vario-group or the Vivity-group at a 1:1 ratio. Patients and study-optometrists will be masked. Surgeons are impossible to mask, due to the difference in (optical) design between both IOLs. Patients will receive standard cataract extractions by experienced surgeons.

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 19, 2022
• Study Start: May 2, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)