Cataract
Conditions
Keywords
Cataract, Cataract surgery, intraocular surgery
Brief summary
Comparison of the visual function of two enhanced monofocal intraocular lenses after cataract surgery
Detailed description
Cataracts remain the leading cause of preventable blindness in many developing countries. Over the past decades, cataract surgery has undergone significant advancements. With the development of refined surgical techniques, such as smaller incisions, and the introduction of advanced intraocular lens (IOL) technologies, the procedure has transformed into a refractive approach for visual rehabilitation. The primary goal is to achieve a high level of spectacle independence for patient. Monofocal lenses are designed with a single fixed focal length and refractive power. While they provide excellent distance vision, patients still need glasses for intermediate and near vision. However, modern patients have increasingly high expectations, often seeking full independence from spectacles after cataract surgery. This growing demand has fueled ongoing research and innovation in the development of advanced IOLs. In contrast, enhanced monofocal IOLs offer optical properties that deliver good intermediate vision outcomes without the negative aspects of multifocal IOLs such as photic phenomena or loss in contrast vision. The aim of the study is therefore to compare two refractive enhanced monofocal IOLs in an intra-individual approach. 60 eyes of 30 patients will be included into this study. After randomization one eye is implanted with the Art 25 IOL, whereas the other eye gets the Eyhance IOL. Follow-up visits will be 1 week and 3 months after the surgery.
Interventions
DEVICEenhanced monofocal IOL
Art 25 IOL, enhanced monofocal IOL
Sponsors
Vienna Institute for Research in Ocular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 * Axial length: 21.00-27.00mm * Astigmatism \< 1.0 dpt * Normal findings in the medical history and physical examination * Written informed consent prior to surgery
Exclusion criteria
* Reduced contrast vision, binocularity or stereoscopic vision (e.g. amblyopia, strabismus) * 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 * Irregular astigmatism on corneal tomography * Pronounced dry eye disease * Nystagmus or pathologies that might affect patient's fixation * Previous ocular surgery or trauma * Persons who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance-corrected intermediate visual acuity | 3 months | The difference in distance-corrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected intermediate visual acuity | 3 months | The difference in uncorrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs |
| Corrected and uncorrected distance visual acuity | 3 months | The difference in corrected and uncorrected distance visual acuity before and after surgery will be measured at 4 m and compared between the two different IOLs |
| Corrected and uncorrected near visual acuity | 3 months | The difference in corrected and uncorrected near visual acuity before and after surgery will be measured at 40 cm and compared between the two different IOLs |
| Defocus curve | 3 months | The difference in visual acuity assessed in the defocus curve before and after surgery and compared between the two different IOLs |
| Contrast Sensitivity | 3 months | The difference in contrast sensitivity between the two different IOLs |
Countries
Austria
Contacts
Primary ContactOliver Findl, Prim. Univ.-Prof. Dr.
Backup ContactManuel Ruiss, MSc.
Outcome results
None listed