Myopic Monovision: EDOF vs. Monofocal IOL

Comparison Between Bilateral Extended Depth of Focus (EDOF) Intraocular Lens Myopic Monovision and Monofocal Intraocular Lens Myopic Monovision for Myopic Patients: a Randomised Trial

Comparison of EDOF IOLs versus monofocal IOLs with mini-monovision concerning intermediate and near visual acuity.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: enhanced depth of focus IOL; Device: monofocal IOL

Detailed Description

Spectacle independence is one of the main aims in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satifsfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result.

There are different techniques to reduce spectacle dependence, the most common one is the use of multifocal IOLs. However, a variable number of patients complain of problems, such as glare or haloes. It appears that multifocal IOL technology does lead to less satisfying results in patients with pre-operative myopia. These patients are used to very good near vision when taking off their spectacles. Many of these patients would prefer to keep their distance spectacles and ideally would like to function well at intermediate and near distance without glasses for e.g. reading and computer- or household work.

One option to enhance intermediate vision and to leave patients with good contrast sensitivity is the use of extended depth of focus (EDOF) IOLs. One example is the ACUNEX Vario AN6V with a near add of 1.50 D. In particular, this design provides improved vision at a distance of 66 cm and more. Additional key features of the low-add IOL include good contrast sensitivity for twilight vision, optimized depth of focus, and natural imaging quality and color sensitivity.

Another option to allow spectacle independence is (mini-)monovision. For some people, who are in need of intermediate and near reading vision most of the time, mini-monovision with one eye having intermediate (arms length) and one eye having near (reading) vision is a good option ("myopic monovision").

Hence, the aim of the study is to analyse intermediate and near vision outcomes in myopic patients with either EDOF IOLs or monofocal IOLs with mini-monovision.

124 eyes of 62 patients will be included into this study. According to randomization, 31 patients will receive the EDOF IOLs (Acunex Vario AN6V) bilaterally, whereas in the other 31 patients a monofocal IOL (Acunex AN6) with mini-monovision will be implanted bilaterally. Follow-Up visits will be 1 hour, 1 week, and 2 months after surgery. A slit lamp examination, autorefraction and subjective refraction as well as visual acuity testing, reading performance, stereo vision testing and defocus curve assessment will be performed at this visits.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Falasinnu, MD; Phone Number: 57564 01 91021; Email: office@viros.at
• Study Contact Backup: Name: Oliver Findl, MD; Phone Number: 57564 01 91021; Email: office@viros.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
    • Contact: John Falasinnu, MD; Phone Number: 57564 01 91021; Email: office@viros.at
    • Contact: Oliver Findl, MD; Phone Number: 57564 01 91021; Email: office@viros.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age-related cataract in both eyes
• bilateral cataract surgery
• motivated to be less spectacle dependent in the intermediate to near vision range
• expected CDVA of 0.8 snellen or better
• myopic patients with shorter eye having an axial length of at least 25.5 mm
• age 21 and older
• planned postoperative astigmatis lower than or 0.75 D
• written informed consent prior to recruitment

Exclusion Criteria:

• pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
• retinitis pigmentosa
• chronic uveitis
• amblyopia
• pupil decentration > 0.8 mm, pupil size < 2.8 mm
• preceded retinal surgery
• preceded LASIK
• any ophthalmic abnormality that could compromise visual function or the measurements

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acunex Vario AN6V; Patient will receive the enhanced depth of focus IOL during cataract surgery	Device: enhanced depth of focus IOL; Acunex Vario AN6V, enhanced depth of focus IOL
Experimental: Acunex AN6; Patient will receive the monofocal IOL during cataract surgery	Device: monofocal IOL; Acunex AN6, monofocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectacle independence	Spectacle independence will be assessed using a questionnaire and compared between patients with EDOF IOLs and patients with the monofocal IOL	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Visual acuity will be assessed using ETDRS charts and will be compared between patients with the EDOF IOLs and patients with the monofocal IOLs	24 months
Reading speed	Reading speed will be analysed by using the Salzburg Reading Desk and will be compared between patients with the EDOF IOLs and patients with the monofocal IOLs	24 months
Stereo vision	Stereo vision will be analysed by using a 3D-computer program and will be compared between patients with the EDOF IOLs and patients with the monofocal IOLs	24 months

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cataract; Myopia; enhanced depth of focus intraocular lens; mini-monovision
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Myopic Monovision

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