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Premium Trifocal IOL Comparative Analysis

Primary Purpose

Cataract, Lens Opacities, Presbyopia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular lens, Trifocal

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Augenklinik Ahaus
Internationale Innovative Ophthalmochirgie
Universitäts-Augenklinik Heidelberg
Augentagesklinik Rheine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04875455

First Posted

May 1, 2021

Last Updated

January 7, 2022

Sponsor

Beaver-Visitec International, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04875455

Brief Title

Premium Trifocal IOL Comparative Analysis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

November 17, 2021 (Actual)

Study Completion Date

November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract, Lens Opacities, Presbyopia

Keywords

Intraocular lens, Trifocal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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, intraocular

Masking

None (Open Label)

Allocation

N/A

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Monocular Best corrected distance visual acuity (5 m)

Description

CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.

Time Frame

Postoperative Day 75-105 (3 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerd Auffarth, MD, PhD

Organizational Affiliation

University Hospital Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Augenklinik Ahaus

City

Ahaus

ZIP/Postal Code

48683

Country

Germany

Facility Name

Internationale Innovative Ophthalmochirgie

City

Düsseldorf

ZIP/Postal Code

40212

Country

Germany

Facility Name

Universitäts-Augenklinik Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Augentagesklinik Rheine

City

Rheine

ZIP/Postal Code

48429

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

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