Comparison of clinical outcomes of 2 "premium" intraocular lenses
Résumé de l'étude
Intraocular lenses (IOLs) are artificial lenses that are inserted ("implanted") into the eyes, in place of the cloudy natural lens, during cataract surgery. Their purpose is to restore vision. There are several types of IOLs. This study will use and investigate premium monofocal IOLs, whose optical properties allow for clear distance vision as well as good intermediate vision. This IOL will be compared to an extended depth of focus IOL. With both lenses, the goal is to achieve not only good clear vision at distance but also good vision in the intermediate zone, at a distance of approximately 80-114 cm. If the subject meets the criteria to participate in the study and the said person agrees to participate, they will receive either the study lens Isopure 1.2.3. in both eyes or the comparator lens Tecnis Eyhance in both eyes during cataract surgery. The assignment of one of the two lenses is done randomly. The investigator has no influence on this assignment process. The same number of patients will be equipped with the study lens and the comparator lens. This is a national study conducted at a single ophthalmological center (Vista Alpina) with the participation of 68 patients. The total duration of the study is approximately 8 months maximum for you and includes the pre-operative exam, surgery, and 4 follow-up appointments.
(BASEC)
Intervention étudiée
Since both lenses are CE marked, they have already been subject to previous clinical trials in order to be marketed in Europe. Furthermore, both lenses are used exclusively for the indications for which they have been CE certified.
For this reason, only the results of vision quality will be studied. For this study, specifically: the quality of distance vision and intermediate zone vision will be studied.
As with any other study of IOL implantation post-cataract, safety data will also be analyzed.
Subsequently, the results of the two groups: implantation with Isopure 1.2.3 and implantation with Tecnis Eyhance will be compared.
(BASEC)
Maladie en cours d'investigation
Cataract is the clouding of the natural lens of the eye (crystalline lens). This condition leads to vision impairment and can cause blindness if left untreated. Cataract surgery involves replacing the cloudy natural lens with an artificial lens (also known as an intraocular lens) to restore vision.
(BASEC)
- Have signed a standard informed consent form for cataract surgery and the choice of EDOF lens implantation, before being informed of the possibility of participating in a clinical investigation. - Eyes with senile cataract without comorbidity - Adults of either sex aged 50 years or older - Expected postoperative best corrected distance visual acuity (CDVA) ≤ 0.2 logMAR (BASEC)
Critères d'exclusion
- Regular total corneal astigmatism >1.0 diopter - Irregular astigmatism - Subjects with diagnosed visual disorders other than cataract - Previous intraocular or corneal surgery or intravitreal injection - Traumatic cataract - History or presence of macular edema - Ocular hypertension or glaucoma - Pupillary anomalies - Amblyopia with preoperative monocular CDVA of >0.1 logMAR - Cornea guttata - Keratoconus - Chronic uveitis - Expected complicated surgery - Significant dry eye (BASEC)
Lieu de l’étude
Sion, Autre
(BASEC)
Sierre et Visp (autres cabinets qui appartiennent à la même clinique)
(BASEC)
Sponsor
Centre oculaire Vista Alpina
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Kristof Vandekerckhove
+41 (0)27 946 70 00
vandekerckhove@cluttervista-alpina.chCentre oculaire Vista Alpina
(BASEC)
Informations générales
Eye center Vista Alpina
(ICTRP)
Informations scientifiques
Eye center Vista Alpina
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
24.07.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT05235139 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of ISOPURE and EYHANCEIntraocular Lenses (IOL) Using a Double-masked Study Design (BASEC)
Titre académique
Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular Lens (IOL) in Comparison to an EDOF Lens (ICTRP)
Titre public
PMCF Study on Comparison of EDOF Lenses (Switzerland) (ICTRP)
Maladie en cours d'investigation
Cataract;Lens Opacities (ICTRP)
Intervention étudiée
Device: IOL implantation experimental (ISOPURE 1.2.3.);Device: IOL implantation active comparator (Acrysof Vivity) (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 50 Years
Inclusion Criteria:
- Cataractous eyes with no comorbidity;
- Calculated IOL power is within the range of the study IOLs;
- Male or female adults ages 50 years or older on the day of screening who have
cataract(s) in one or both eyes;
- Regular total corneal astigmatism =1.0 D (measured by topography method)
- Clear intraocular media other than cataract;
- Availability, willingness and sufficient cognitive awareness to comply with
examination procedures;
- Expected postoperative Best Corrected Distance Visual Acuity (CDVA) = 0.2 logMAR;
- Signed informed consent.
Exclusion Criteria:
- Age of patient < 50 years;
- Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
- Irregular astigmatism;
- Difficulty for cooperation (distance from their home, general health conditions);
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or
other retinal or optic disorders);
- Subjects who may be expected to require retinal laser treatment during the course of
the study or at a greater risk of developing cystoid macular edema or macula pucker;
- Previous intraocular or corneal surgery or intravitreal injection;
- Traumatic cataract;
- History or presence of macular edema;
- Glaucoma with visual field defects;
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils
that do not dilate under mesopic / scotopic conditions);
- Amblyopia with monocular preoperative CDVA of >0.1 logMAR;
- Cornea guttata;
- Keratoconus;
- Chronic uveitis;
- Expected complicated surgery;
- Significant dry eye;
- Contra-indications as listed in the current Instructions for use (IFU);
- Contra-indication or unwillingness to perform immediate sequential bilateral cataract
surgery;
- Concurrent or previous (within 60 days) participation in another drug or device
investigation.
In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued
when certain conditions are present at the time of surgery, including:
- zonular instability or defect;
- capsular fibrosis or other opacity; and
- inability to fixate IOL in desired position. In such cases, the subject shall be
followed until the condition has stabilized.
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye. (ICTRP)
Safety (Rates of Adverse Events) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
targomedGmbH (ICTRP)
Contacts supplémentaires
Kristof Vandekerkchove, MD, Eye center Vista Alpina (ICTRP)
ID secondaires
PHY2130 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05235139 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible