NCT05779306

Brief Summary

To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J\&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

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

January 19, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

March 9, 2023

Last Update Submit

March 7, 2024

Conditions

Cataract ComplicatedCataract Complications Operations

Outcome Measures

Primary Outcomes (5)

  • Tilt

    Postoperative Tilt

    6 Weeks

  • Autorefraction

    Refraction using an automated refractor

    6 Weeks

  • Subjective Refraction

    Refraction performed by experienced staff

    6 Weeks

  • Best corrected visual acuity

    Measurement performed by experienced staff

    6 Weeks

  • uncorrected visual acuity

    Measurement performed by experienced staff

    6 Weeks

Study Arms (2)

Carlevale

Patients who had a Carlevale lens implanted

Device: IOL Master 700Device: Casia-2Device: MS-39Device: OSIRISDevice: AutorefractorDiagnostic Test: Subjective Refraction

Yamane

Patients who had a lens implanted using Yamane technique

Device: IOL Master 700Device: Casia-2Device: MS-39Device: OSIRISDevice: AutorefractorDiagnostic Test: Subjective Refraction

Interventions

IOL Master 700DEVICE

Biometry using the IOL Master 700

CarlevaleYamane
Casia-2DEVICE

Anterior segment-OCT to evaluate lens tilt

CarlevaleYamane
MS-39DEVICE

Corneal Topography using the MS-39

CarlevaleYamane
OSIRISDEVICE

Abberometry using the OSIRIS-Abberometer

CarlevaleYamane
AutorefractorDEVICE

Evaluation of Refraction using an Autorefractor

CarlevaleYamane
Subjective RefractionDIAGNOSTIC_TEST

Refraction performed by experienced staff

CarlevaleYamane

Eligibility Criteria

Age21 Years - 110 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients recruited all underwent ocular surgery with implantation of a scleral fixated lens, either using the Carlevale lens or the Yamane technique

You may qualify if:

  • minimum age of 21 years
  • planned surgery or already taken place surgery using a scleral fixated lens

You may not qualify if:

  • best corrected visual acuity \<0.05 Snellen
  • pregnancy
  • missing informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Capsule Opacification

Condition Hierarchy (Ancestors)

CataractLens DiseasesEye Diseases

Study Officials

  • Nino Hirnschall, MD

    Johannes Kepler University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

January 19, 2023

Primary Completion

January 1, 2024

Study Completion

January 30, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)