Overview
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.
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.
Eligibility
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