Clinical trial NCT04875455: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular lens
Trifocal
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 133
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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, intraocular
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Monocular Best corrected distance visual acuity (5 m)
timeFrame: Postoperative Day 75-105 (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Ahaus
country: Germany
facility: Augenklinik Ahaus
city: Düsseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirgie
city: Heidelberg
country: Germany
facility: Universitäts-Augenklinik Heidelberg
city: Rheine
country: Germany
facility: Augentagesklinik Rheine
Study officials:
affiliation: University Hospital Heidelberg
name: Gerd Auffarth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: