Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses

NCT ID: NCT06607848

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2026-07-01

Brief Summary

Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.

Detailed Description

Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.

Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.

The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.

The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo&glare, optical coherence tomography, fundus examination, aberrometry and keratometry.

The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.

Conditions

Cataract

Study Design

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

Study Groups

Acunex Vario AN6V

Patients will receive the Acunex IOL during cataract surgery

Group Type: EXPERIMENTAL

Low-Add EDOF IOL

Intervention Type: DEVICE

Acunex Vario AN6V

PureSee

Patients will receive the PureSee IOL during cataract surgery

Group Type: EXPERIMENTAL

EDOF IOL

Intervention Type: DEVICE

PureSee EDOF IOL

Interventions

Low-Add EDOF IOL

Acunex Vario AN6V

Intervention Type: DEVICE

EDOF IOL

PureSee EDOF IOL

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age-related bilateral cataract
• Age 21 or older
• Visual acuity > 0.05
• For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
• Written informed consent prior to surgery

Exclusion Criteria

• Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
• Corneal decompensation or corneal endothelial cell insufficiency
• Irregular astigmatism on corneal tomography
• Pronounced dry eye disease
• Previous ocular surgery or trauma
• Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)

• 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, Univ. Prof. Prim. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery (VIROS)

Locations

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

Vienna, Austria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Johannes Zeilinger, MD

Role: CONTACT

office@viros.at

01 91021 57564

Manuel Ruiss, MSc

Role: CONTACT

office@viros.at

01 91021 57564

Facility Contacts

Johannes Zeilinger, MD

Role: primary

office@viros.at

01 91021 57564

Manuel Ruiss, Mac

Role: backup

office@viros.at

01 91021 57564

Other Identifiers

Vario vs. PureSee

Identifier Type: -

Identifier Source: org_study_id