Myopic Monovision: EDOF vs. Monofocal IOL

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194670
• Other study ID #: Myopic Monovision
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2022
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: John Falasinnu, MD
• Phone: 01 91021
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• enhanced depth of focus IOL
Acunex Vario AN6V, enhanced depth of focus IOL
• monofocal IOL
Acunex AN6, monofocal IOL

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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