NCT06294405

Brief Summary

The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress44%
Feb 2024Feb 2029

First Submitted

Initial submission to the registry

February 20, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2029

Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

February 20, 2024

Last Update Submit

March 4, 2024

Conditions

Intraocular Lens ComplicationIntraocular Lens RotationIntraocular Lens Associated Postoperative InflammationLens Opacities

Outcome Measures

Primary Outcomes (3)

  • Functional results with different Intraocular lenses

    Visual acuity with different intraocular lenses is determined.

    6 months

  • Contrast sestivitiy with different Intraocular lenses

    Contrast sensitivity with different intraocular lenses is determined.

    6 months

  • Anatomical results.

    Anatomical results with different intraocular lenses are determined.

    6 months

Interventions

Intraocular lens ImplantationDEVICE

Intraocular lenses are implanted during cataract surgery to replace the human crystalline lens.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive an intraocular lens are offered to participate in the study.

You may qualify if:

  • Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity

You may not qualify if:

  • Dementia Pregnancy Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Augsburg

Augsburg, Germany

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Isabella Baur, MD

CONTACT

0049821 400-2566Isabella.Baur@uk-augsburg.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

February 20, 2024

First Posted

March 5, 2024

Study Start

February 21, 2024

Primary Completion (Estimated)

February 14, 2029

Study Completion (Estimated)

February 14, 2029

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)