Premium Trifocal IOL Comparative Analysis

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875455
• Other study ID #: PHY1705
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: November 17, 2021

Study information

• Verified date: January 2022
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Lens Opacities
• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
Germany	Augenklinik Ahaus	Ahaus
Germany	Internationale Innovative Ophthalmochirgie	Düsseldorf
Germany	Universitäts-Augenklinik Heidelberg	Heidelberg
Germany	Augentagesklinik Rheine	Rheine

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)