Premium Trifocal IOL Comparative Analysis

Development of a Database (Register) for Quality Assurance and Optimization of the Postoperative Results of Premium Intraocular Lenses

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia; Lens Opacities
• Intervention / Treatment: Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation

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

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ahaus, Germany, 48683
    • Augenklinik Ahaus
  • Düsseldorf, Germany, 40212
    • Internationale Innovative Ophthalmochirgie
  • Heidelberg, Germany, 69120
    • Universitäts-Augenklinik Heidelberg
  • Rheine, Germany, 48429
    • Augentagesklinik Rheine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Best corrected distance visual acuity (5 m)	CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.	Postoperative Day 75-105 (3 months)

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: Gerd Auffarth, MD, PhD, University hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: May 1, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Intraocular lens; Trifocal
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: PHY1705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No