Cataract
Conditions
Keywords
EDOF IOL, presbyopia-correction, Cataract
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.
Interventions
DEVICELow-Add EDOF IOL
Acunex Vario AN6V
DEVICEEDOF IOL
PureSee EDOF IOL
Sponsors
Vienna Institute for Research in Ocular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 105 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance corrected visual acuity for intermediate distance | 6 months | Distance corrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected and distance corrected visual acuity for far distance | 6 months | Uncorrected and distance corrected visual acuity for far distance given in logMAR will be measured at 4 m using ETDRS charts |
| Uncorrected and distance corrected visual acuity for near distance | 6 months | Uncorrected and distance corrected visual acuity for near distance given in logMAR will be measured at 40 cm using ETDRS charts |
| Defocus curve assessment | 6 months | Monocular defocus curves will be assessed in logMAR at 4 m using an ETDRS chart |
| Uncorrected visual acuity for intermediate distance | 6 months | Uncorrected visual acuity for intermediate distance given in logMAR will be measured at 66 cm using ETDRS charts |
| Contrast sensitivity | 6 months | Contrast sensitivity will be tested using the Optec device |
| Subjective rating of dysphotopsia | 6 months | Dysphotopsia will be subjectively rated by the patients using a questionnaire and a visual analogue scale |
| Halometry | 6 months | Potential halos will be assessed using the Aston Halometer App provided on a Tablet at 2 m |
Countries
Austria
Contacts
Primary ContactJohannes Zeilinger, MD
Backup ContactManuel Ruiss, MSc
Outcome results
None listed