NCT04875455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

May 1, 2021

Last Update Submit

January 7, 2022

Conditions

CataractLens OpacitiesPresbyopia

Keywords

Intraocular lensTrifocal

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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.

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

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Augenklinik Ahaus

Ahaus, 48683, Germany

Location

Internationale Innovative Ophthalmochirgie

Düsseldorf, 40212, Germany

Location

Universitäts-Augenklinik Heidelberg

Heidelberg, 69120, Germany

Location

Augentagesklinik Rheine

Rheine, 48429, Germany

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Gerd Auffarth, MD, PhD

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 6, 2021

Study Start

November 1, 2017

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(4)