Clinical trial NCT06607848: Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses
Official title: Intraindividual Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses Set for Emmetropia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cataract
Keywords: EDOF IOL
presbyopia-correction
Cataract
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&amp;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.

Eligibility criteria: Inclusion Criteria:

* Age-related bilateral cataract
* Age 21 or older
* Visual acuity \&gt; 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)

Primary outcomes:
measure: Distance corrected visual acuity for intermediate distance
timeFrame: 6 months
Secondary outcomes:
measure: Uncorrected visual acuity for intermediate distance
timeFrame: 6 months
measure: Uncorrected and distance corrected visual acuity for far distance
timeFrame: 6 months
measure: Uncorrected and distance corrected visual acuity for near distance
timeFrame: 6 months
measure: Defocus curve assessment
timeFrame: 6 months
measure: Halometry
timeFrame: 6 months
measure: Contrast sensitivity
timeFrame: 6 months
measure: Subjective rating of dysphotopsia
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery (VIROS)
name: Oliver Findl, Univ. Prof. Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References: