Myopic Monovision: EDOF vs. Monofocal IOL

NCT ID: NCT05194670

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2024-08-01

Brief Summary

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

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acunex Vario AN6V

Patient will receive the enhanced depth of focus IOL during cataract surgery

Group Type: EXPERIMENTAL

enhanced depth of focus IOL

Intervention Type: DEVICE

Acunex Vario AN6V, enhanced depth of focus IOL

Acunex AN6

Patient will receive the monofocal IOL during cataract surgery

Group Type: EXPERIMENTAL

monofocal IOL

Intervention Type: DEVICE

Acunex AN6, monofocal IOL

Interventions

enhanced depth of focus IOL

Acunex Vario AN6V, enhanced depth of focus IOL

Intervention Type: DEVICE

monofocal IOL

Acunex AN6, monofocal IOL

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, MD

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Locations

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

John Falasinnu, MD

Role: CONTACT

office@viros.at

01 91021 ext. 57564

Oliver Findl, MD

Role: CONTACT

office@viros.at

01 91021 ext. 57564

Facility Contacts

John Falasinnu, MD

Role: primary

office@viros.at

01 91021 ext. 57564

Oliver Findl, MD

Role: backup

office@viros.at

01 91021 ext. 57564

Other Identifiers

Myopic Monovision

Identifier Type: -

Identifier Source: org_study_id