Premium Trifocal IOL Comparative Analysis

Beaver-Visitec

Status: Completed

Conditions: Cataract; Presbyopia; Lens Opacities

Treatments: Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04875455

PHY1705

Details and patient eligibility

About

Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.

Full description

Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.

Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak & Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.

Main objectives:

1. Functional results (refraction and visual acuity results) Secondary goals:
2. Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
3. Subjective patient satisfaction
4. Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
5. Stability of the results achieved postoperatively

Enrollment: 133 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Bilateral implantation of one of the following IOL models
• Alcon PanOptix (TFNT00)
• PhysIOL FineVision (POD F)
• PhysIOL FineVision (POD F GF)
• Uneventful cataract surgery with first clinical outcomes in the expected range
• Patient included in Premium IOL study protocol by signed informed consent

Exclusion criteria

• Age of patient <45 years
• Irregular astigmatism
• Postoperative manifested astigmatism of >1.0 D
• Difficulty for cooperation (distance from their home, general health condition)
• Clinically significant glaucoma
• Clinically significant macular degeneration, clinically significant macular edema or proliferative diabetic retinopathy
• Patients with keratoconus or keratectasia
• Any ocular comorbidity having a significant effect on the postoperative clinical outcomes
• History of ocular trauma or prior ocular surgery including refractive procedures
• Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
• Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
• AMD
• Intraoperative complications like capsular rupture etc.
• Patients who do not give informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

Experimental: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation

Experimental group

Description:

PhysIOL POD F GF: 50 (bilateral implantation) PhysIOL POD F: 50 (bilateral implantation) Alcon PanOptix: 20 (bilateral implantation) In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.

Treatment:

Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation