- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07925840
Rotational Stability of the Acunex Vario Toric
Evaluation of the Rotational Stability of the Acunex Vario Toric Intraocular Lens
Efficacy of the rotational stability and astigmatism correction of a toric EDOF IOL, the Acunex Vario toric.
Studieöversikt
Detaljerad beskrivning
Recent advances in cataract surgery technology have transformed the procedure from a purely vision-restoring approach into a procedure for correcting presbyopia. Patients' resulting higher expectations regarding freedom from spectacles have led to advances in intraocular lens (IOL) technology in recent years. The implantation of a standard monofocal IOL designed to achieve emmetropia results in a high level of patient satisfaction with regard to distance vision. However, spectacles are still required for intermediate and near vision.
One approach to achieving freedom from spectacles at all distances is the use of multifocal IOLs. Compared with monofocal IOLs, however, these lenses are more frequently associated with photic phenomena such as glare and halos, as well as reduced contrast sensitivity. Another approach to minimize the need for spectacles is the use of IOLs with extended depth of focus (EDOF). These lenses feature an extended distance focus range that extends into the intermediate range, thereby offering high visual quality across a continuous focus range. Unlike trifocal IOLs, which split the light into different focal points, the extended focus of these IOLs is designed to improve contrast perception in the intermediate range and reduce light-related phenomena.
Furthermore, residual corneal astigmatism is an important factor in achieving post-operative freedom from spectacles, and its correction is necessary to achieve the best possible visual performance. The most widely used and effective approach to correcting corneal astigmatism is the implantation of a toric IOL. To ensure that these lenses achieve the desired effect, they must be positioned precisely along the intended axis, as any rotation of a toric IOL can reduce its ability to correct astigmatism.
Particularly in the case of IOLs designed to correct presbyopia, such as trifocal or EDOF lenses, it is therefore important to correct corneal astigmatism in order to achieve the best possible post-operative visual outcome. The aim of this study is therefore to analyze the efficacy and rotational stability of a toric EDOF IOL (Acunex Vario toric, AN6VT).
38 eyes from 38 patients will be included into the study, into each eye an AN6VT IOL will be implanted. Follow-up examinations will take place 1 hour, 1 week after surgery on the first eye and 1 week after surgery on the second eye, and 4-6 months post-operatively.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Johannes Zeilinger, MD
- Telefonnummer: 57564 +43 1 91021
- E-post: office@viros.at
Studera Kontakt Backup
- Namn: Oliver Findl, Prim. Prof. Dr.
- Telefonnummer: 57564 +43 1 91021
- E-post: office@viros.at
Studieorter
-
-
-
Vienna, Österrike, 1140
- Rekrytering
- Vienna Institute for Research in Ocular Surgery
-
Kontakt:
- Johannes Zeilinger, MD
- Telefonnummer: 57564 +43 1 91021
- E-post: office@viros.at
-
Kontakt:
- Oliver Findl, Prim. Prof. Dr.
- Telefonnummer: 57564 +43 1 91021
- E-post: office@viros.at
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Bilateral age-related cataract scheduled for cataract surgery
- Age 21 or older
- Predefined postoperative residual astigmatism to be < 0.5 D (calculated with Barrett total K toric calculator)
- Calculated IOL power within the range of the investigated IOL
- Pupil size ≥ 5 mm (in mydriasis)
- Willingness to comply with the postoperative follow-up examination schedule
- Written informed consent prior to surgery
Exclusion Criteria:
- Previous ocular surgery or trauma
- Extreme shallow anterior chamber
- Uncontrolled systemic or ocular disease
- Associated corneal pathologies (e.g., edema, scarring) or relevant other ophthalmic diseases that may result in altered visual outcome or lens stability (e.g., pseudoexfoliation syndrome, floppy iris syndrome, glaucoma, retinal disease)
- Concurrent participation in another clinical investigation
- Pregnancy or lactation (pregnancy test will be performed in women of reproductive age)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Acunex Vario toric
Patient will recieve the Acunex Vario IOL during cataract surgery |
The Acunex Vario toric IOL, toric EDOF IOL, will be implanted |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
IOL axis rotation
Tidsram: 12 monthes
|
The IOL axis rotation before and after cataract surgery will be analyzed with retroillumination photographs |
12 monthes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Distance visual acuity
Tidsram: 12 months
|
Uncorrected and corrected distance visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 4 metres |
12 months
|
|
Intermediate visual acuity
Tidsram: 12 months
|
Uncorrected and corrected intermediate visual acuity before and after cataract surgery will be determined using ETDRS-charts in a distance of 66 centimetres |
12 months
|
|
Refraction
Tidsram: 12 months
|
Refraction before and after cataract surgery will be determined using trial frame glasses and Jackson cross cylinders |
12 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Oliver Findl, Prim. Prof. Dr., Vienna Institute for Research in Ocular Surgery
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Acunex Vario toric
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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