Premium Trifocal IOL Comparative Analysis

Sponsor

Beaver-Visitec International, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04875455

Collaborator

(none)

133

Enrollment

Locations

Arm

48.5

Actual Duration (Months)

33.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Lens Opacities Presbyopia	Device: POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation	N/A

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

133 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Study procedure guidelines Patients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included: Retrospective: Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectively Prospective: 2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocularStudy procedure guidelinesPatients who were previously treated with a premium IOL (Panoptix, POD FGF, POD F) are continuously included:Retrospective:Routine data collected up to the first study visit (preoperative, intraoperative and postoperative) are evaluated retrospectivelyProspective:2-4 months postoperatively: refraction and vision, slit lamp and fundus examination, intraocular

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Nov 17, 2021

Actual Study Completion Date :

Nov 17, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Augenklinik Ahaus	Ahaus	Germany	48683
2	Internationale Innovative Ophthalmochirgie	Düsseldorf	Germany	40212
3	Universitäts-Augenklinik Heidelberg	Heidelberg	Germany	69120
4	Augentagesklinik Rheine	Rheine	Germany	48429

Sponsors and Collaborators

Beaver-Visitec International, Inc.

Investigators

Principal Investigator: Gerd Auffarth, MD, PhD, University Hospital Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Beaver-Visitec International, Inc.

ClinicalTrials.gov Identifier:

NCT04875455

Other Study ID Numbers:

PHY1705

First Posted:

May 6, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Beaver-Visitec International, Inc.

Intraocular lens

Trifocal

Additional relevant MeSH terms:

Cataract

Presbyopia

Study Results

No Results Posted as of Jan 11, 2022