Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

Cataract Clinical Trial

Official title:

Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345820
• Other study ID #: Evolux
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Andreas Rotter, MD
• Phone: 01 91021
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.

Description:

In modern cataract surgery the aim of the procedure is not just the restoration of vision but to also achieve some spectacle independence. Bilateral implantation of monofocal intraocular lenses (IOL) aiming for emmetropia lead to high patient satisfaction levels in distance vision but leave patients dependent on spectacles in intermediate and near vision tasks.

To achieve high levels of spectacle independence the most commonly used option are multifocal intraocular lenses (MIOL). These MIOLs use either a refractive or diffractive optical design, a combination of both or segmented asymmetric optics. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. However, a portion of patients experience problems with positive dysphotopsia symptoms such as halos and glare. Other potentially negative aspects of MIOLs are pupil size dependency and loss of light energy to higher order diffraction which can lead to reduced contrast sensitivity. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and positive dysphotopsia phenomena than refractive multifocal lenses.

A newer concept of IOLs are non-diffractive enhanced range of vision (EROV) IOLs, sometimes also referred to as EDOF IOLs. The EROV IOLs with the least compromise concerning quality of vision are the group of so called enhanced monofocal IOL, also sometime referred to as monofocal plus IOL. These IOLs should result in better intermediate vison and provide contrast sensitivity and dysphotopsia results comparable to standard monofocal IOLs. These IOLs may be more adequate to meet the expectations of many presbyopic cataract patients, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery.

The aim of this study is to compare the clinical performance of a newer enhanced monofocal IOL (Evolux) with a standard enhanced monofocal IOL, the Tecnis Eyhance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

Inclusion Criteria:

• Bilateral cataract

• Age 21 or older

• Visual acuity > 0.05

• Axial length: 22.00-26.00mm

• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

• Written informed consent prior to surgery

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)

• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)

• Corneal decompensation or corneal endothelial cell insufficiency

• Amblyopia

• Previous ocular surgery or trauma

• Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)

• Astigmatism with the need for a toric IOL

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Evolux
Evolux, enhanced monofocal IOL
• Tecnis Eyhance
Tecnis Eyhance, enhanced 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	Monocular intermediate visual acuity	Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts	24 months
Secondary	Monocular distance visual acuity	Monocular distance visual acuity at 4 meters will be measured using ETDRS charts	24 months
Secondary	Monocular near visual acuity	Monocular near visual acuity at 40 cm will be measured using ETDRS charts	24 months