Intraocular Lens Implant Registry Study

March 4, 2024 updated by: Dr. med.Isabella Baur, University Hospital Augsburg

Development of a Database to Optimize the Results With Intraocular Lens Implants

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field.

In the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes.

Patients treated with an intraocular lens implant will be included. The retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). Prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. Depending on the type of IOL, results of further non-invasive measurements are also recorded. Optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Augsburg, Germany
        • Recruiting
        • University Hospital Augsburg
        • Contact:
          • Isabella Baur, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Dementia Pregnancy Breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional results with different Intraocular lenses
Time Frame: 6 months
Visual acuity with different intraocular lenses is determined.
6 months
Contrast sestivitiy with different Intraocular lenses
Time Frame: 6 months
Contrast sensitivity with different intraocular lenses is determined.
6 months
Anatomical results.
Time Frame: 6 months
Anatomical results with different intraocular lenses are determined.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Augsburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2024

Primary Completion (Estimated)

February 14, 2029

Study Completion (Estimated)

February 14, 2029

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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