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NCT06294405 Clinical Trial

Intraocular Lens Implant Registry Study

Lens Opacities Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06294405
Other study ID # 24-0010
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 21, 2024
Est. completion date February 14, 2029

Study information
Verified date March 2024
Source University Hospital Augsburg
Contact Isabella Baur, MD
Phone 0049821 400-2566
Email Isabella.Baur@uk-augsburg.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date February 14, 2029
Est. primary completion date February 14, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Intraocular lens Implantation
Intraocular lenses are implanted during cataract surgery to replace the human crystalline lens.

Locations
Country Name City State
Germany University Hospital Augsburg Augsburg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional results with different Intraocular lenses Visual acuity with different intraocular lenses is determined. 6 months
Primary Contrast sestivitiy with different Intraocular lenses Contrast sensitivity with different intraocular lenses is determined. 6 months
Primary Anatomical results. Anatomical results with different intraocular lenses are determined. 6 months
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