Evaluating the Safety of the SPECTRALIS CENTAURUS Device

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Retinal Diseases

Treatments: Device: Selective retina therapy SPECTRALIS CENTAURUS device

Study type: Interventional

Funder types: Other

Identifiers

NCT04968756

CENTAURUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 2 weeks
• History of any vitreous haemorrhage within 4 weeks prior to screening or current haemorrhage 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 preceding and during the present study - Inability or lack of willingness to commit to return for all clinical visits and complete all study-related procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment with the SPECTRALIS CENTAURUS device

Experimental group

Description:

In Stage 1, two laser pattern will be applied in areas of the retina that require ablative laser photocoagulation. In Stage 2, a laser pattern will be applied along and on the outside of the arcades. Furthermore, a treatment pattern will be applied to an area temporal to the fovea affected by intermediary age-related macular degeneration (AMD) and confluent soft drusen.

Treatment:

Device: Selective retina therapy SPECTRALIS CENTAURUS device