NCT06345846

Brief Summary

Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

December 30, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

March 28, 2024

Last Update Submit

March 28, 2024

Conditions

Cataract

Keywords

Secondary IOLStability

Outcome Measures

Primary Outcomes (1)

  • Centration of the IOL

    Centration of the IOL will be measured in mm using a Purkinjemeter

    24 months

Secondary Outcomes (1)

  • Tilt of the IOL

    24 months

Study Arms (2)

IFIOL

EXPERIMENTAL

Patients with an implanted IFIOL

Device: IFIOL

SFIOL

EXPERIMENTAL

Patients with an implanted SFIOL

Device: SFIOL

Interventions

IFIOLDEVICE

Implanted IFIOL

IFIOL
SFIOLDEVICE

Implanted SFIOL

SFIOL

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Secondary IOL implantation performed at the Hanusch Hospital
  • IFIOL or SFIOL implanted
  • Older than 21 years
  • Written informed consent prior to recruitment

You may not qualify if:

  • Concurrent participation in another drug or device clinical investigation
  • Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna

Vienna, 1140, Austria

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Oliver Findl, Prim. Dr.

    Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

December 30, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 3, 2024

Record last verified: 2024-03

Locations

AU(1)