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

Last updated: September 19, 2024
Sponsor: Vienna Institute for Research in Ocular Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disease

Vision Loss

Eye Disorders/infections

Treatment

EDOF IOL

Low-Add EDOF IOL

Clinical Study ID

NCT06607848
Vario vs. PureSee
  • Ages 21-105
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 dpttoric IOLs will be implanted

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

  • Written informed consent prior to surgery

Exclusion

Exclusion Criteria:

  • Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucomanot responsive to medication, corneal dystrophies, etc.) precluding goodpost-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 ofreproductive age)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: EDOF IOL
Phase:
Study Start date:
July 29, 2024
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

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

    Vienna, 1140
    Austria

    Active - Recruiting

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