Intraocular Lens Implant Registry Study

Recruiting

• Conditions: Intraocular Lens Rotation; Intraocular Lens Associated Postoperative Inflammation; Lens Opacities; Intraocular Lens Complication

• Registration Number: NCT06294405
• Lead Sponsor: University Hospital Augsburg

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-02-20
• Study Start: 2024-02-21
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2029-02-14
• Study Completion: 2029-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional results with different Intraocular lenses	6 months	Visual acuity with different intraocular lenses is determined.
Contrast sestivitiy with different Intraocular lenses	6 months	Contrast sensitivity with different intraocular lenses is determined.
Anatomical results.	6 months	Anatomical results with different intraocular lenses are determined.

Trial Locations

Locations (1)

University Hospital Augsburg; 🇩🇪 Augsburg, Germany