Evaluating the Safety of the SPECTRALIS CENTAURUS Device

Last updated: January 8, 2024
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Retina

Treatment

Selective retina therapy SPECTRALIS CENTAURUS device

Clinical Study ID

NCT04968756
CENTAURUS
  • Ages 18-95
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written Informed Consent
  • For Stage 1, any patient aged >18 years with the need for conventional laser retinaablation
  • For Stage 2, will be restricted to people aged 50 to <95 years with lesioncharacteristics that meet the criteria for intermediate AMD

Exclusion

Exclusion Criteria:

  • Presence of reticular pseudodrusen
  • Any manifestation of late-stage AMD
  • Known hypersensitivity or allergy to fluorescein or uncontrolled hypertension
  • Concomitant systemic corticosteroid treatment for continuous period longer than 2weeks
  • History of any vitreous haemorrhage within 4 weeks prior to screening or currenthaemorrhage in the study eye
  • Inability to obtain fundus photographs or fluorescein angiogram of sufficient quality
  • Photosensitive epilepsy
  • Insufficient retinal pigmentation (albinism)
  • Corneal opacity / lens opacity
  • Women of child-bearing potential
  • Contralateral eye is at an advanced stage of disease and has poor visual acuity
  • Inability to follow the procedures of the study
  • Participation in another study with investigational drug within the 30 days precedingand during the present study - Inability or lack of willingness to commit to returnfor all clinical visits and complete all study-related procedures

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Selective retina therapy SPECTRALIS CENTAURUS device
Phase:
Study Start date:
September 09, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University Hospital Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

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