Premium Trifocal IOL Comparative Analysis

NCT ID: NCT04875455

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2021-11-17

Brief Summary

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.

Detailed 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

Conditions

Cataract; Lens Opacities; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Interventions

POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerd Auffarth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

Augenklinik Ahaus

Ahaus, , Germany

Internationale Innovative Ophthalmochirgie

Düsseldorf, , Germany

Universitäts-Augenklinik Heidelberg

Heidelberg, , Germany

Augentagesklinik Rheine

Rheine, , Germany

Countries

Germany

Other Identifiers

PHY1705

Identifier Type: -

Identifier Source: org_study_id