NCT04775849

Intraoperative Berger Space Imaging (IBSI)

Intraoperative Berger Space Imaging

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. The laser will be reduced to image the Berger space. If not visible, the space will be enhanced with BSS and Volon A to visualize the BS. Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date. Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination and retinal oct imaging.

Conditions

• Cataract
• Macula Edema

Interventions

Type	Name	Description
DEVICE	Femtosecond Laser	Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral

Timeline

• Start date: 2019-05-20
• Primary completion: 2022-10-31
• Completion: 2022-11-30
• First posted: 2021-03-01
• Last updated: 2021-03-01

Locations

1 site across 1 country: Austria