NCT04968756

Evaluating the Safety of the SPECTRALIS CENTAURUS Device

Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to evaluate the safety of the SPECTRALIS CENTAURUS device (HuCE-optoLab, BFH TI, Biel, CH) in a clinical setting on patients with retinal diseases.

Detailed description

Optical microsurgery of the retinal pigment epithelium (RPE) requires reliable real-time dosimetry to prevent unwanted overexposure of the neuroretina. The SPECTRALIS CENTAURUS device implements optical coherence tomography (OCT) to detect intentional elimination of RPE cells caused by a prototype laser for selective retina therapy (SRT). Within this clinical trial the safety of the SPECTRALIS CENTAURUS device and its ability to detect RPE cell damage towards selective real-time laser microsurgery will be evaluated.

Conditions

• Retinal Diseases

Interventions

Type	Name	Description
DEVICE	Selective retina therapy SPECTRALIS CENTAURUS device	Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device

Timeline

• Start date: 2021-09-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-07-20
• Last updated: 2024-01-11

Locations

1 site across 1 country: Switzerland