Actively Recruiting
Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
Led by Science Corporation · Updated on 2026-04-02
5
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to evaluate the efficacy and safety of the PRIMA Products in participants with inherited retinal degeneration affecting the macula (including but not limited to Stargardt disease, and Retinitis Pigmentosa). Eligible participants will be implanted with the PRIMA Stim implant. The participants will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA Products. The purpose of this study is to gather enough clinical data to support the clinical evaluation required for the continuous development to improve the PRIMA Products.
CONDITIONS
Official Title
Restoration of Central Vision With PRIMA in Patients With Photoreceptor Degeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Is 18 years or older at the date of inclusion
- Has a confirmed diagnosis of inherited retinal degeneration with the macula affected in both eyes
- The study eye has best corrected visual acuity of logMAR 1.2 (20/320) or worse as measured by ETDRS test
- Has an atrophic patch in the study eye including the fovea of at least the implant size (>4.5 mm2 and >2.4 mm in minimum diameter)
- Understands the constraints of the study and accepts to present for all scheduled follow-up visits
- Signed the informed consent
You will not qualify if you...
- Has cataract in the study eye with LOCS III scale NO, NC, C or P >1 (cataract surgery needed before baseline testing; other patients will get IOL replacement during PRIMA Stim implantation)
- Underwent intraocular lens implantation in the study eye within the last month prior to enrolment
- Has an implanted IOL in the study eye and refraction outside of -4D to +4D limit (not relevant for phakic eyes)
- Has a highly myopic study eye (>26 mm AP)
- Has no light perception in either eye
- Has a history of documented choroidal neovascularization in either eye
- Has any signs of exudative AMD including detachment of retinal pigment epithelium in the central visual field of the study eye
- Has an implanted telescope in one eye
- Has a black IOL in the study eye
- Has any disease or condition affecting retinal function or the visual system other than study allowed diseases
- Has any disease or condition preventing adequate examination of the study eye including media opacities not resolved prior to implantation
- Has corneal endothelial cell count less than 1000 cells/mm2 in the study eye
- Suffers from nystagmus or other ocular motility disorders
- Has any disease or condition that precludes understanding or communication of informed consent or study protocols
- Has uncontrolled epileptic seizures
- Has known sensitivity to implant materials (iridium oxide, silicon-carbide, titanium)
- Has known allergy to anaesthetic drugs
- Has hypotonia (<8 mmHg) or hypertonia (>23 mmHg with treatment) in the study eye
- Has active cancer or history of intraocular, optic nerve, or brain cancer with metastasis
- Is immune-suppressed (e.g., HIV positive)
- Is a known carrier of multi-resistant microorganisms
- Is receiving anticoagulation therapy that cannot be adapted for eye surgery
- Is participating in another investigational drug or device study that may interfere
- Has history of chronic or recurrent infection or inflammation precluding participation
- Has significant recurrent or chronic inflammations or infections including severe chronic diseases associated with infection or active eye inflammation
- Has severe psychological disorder
- Does not have mental capacity to legally sign informed consent
- Has severe organ diseases (ASA IV or worse)
- Has head dimensions incompatible with PRIMA Companion glasses
- Has unrealistic expectations about study outcomes
- Has physical constraints making use of PRIMA or rehabilitation impossible
- Is judged unsuitable for participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2006
Actively Recruiting
Research Team
R
Ralf Hornig, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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