Biomarkers for Prognosis in Different Forms of Retinitis Pigmentosa
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Retinal pigment epithelium changes in Retinitis Pigmentosa.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa.
Detailed Description
After a genetic confirmation of RP and classification, the patients will undergo a comprehensive ophthalmological examination that includes the following tests: slit-lamp anterior segment, visual acuity direct and indirect ophthalmoscopy, intraocular pressure, and family history.In order to evaluate the potential role of RPE in the advancement of RP, HD-OCT and OCT angiography images of the outer retina using OCT devices will be performed. Analysis of high-resolution images captured with an ultrawidefield system using a Zeiss Clarus device in order to determine the condition of the peripheral retina.Finally, Flicker Electroretinogram (fERG) performed on the central retina (macula), to assess the central macular function within an 18° field of view. This assessment involved measuring the response of the macula to a flickering stimulus with a frequency of 41 Hz, which is commonly done in routine clinical practice.
Investigators
RIZZO STANISLAO
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •Patients who are able to read and sign informed consent
- •Patients with Retinitis pigmentosa confirmed by genetic test.
- •Patients older than or equal to 18 years of age
Exclusion Criteria
- •Other retinal diseases such as macular hole, retinal detachment, macular neovascularization.
- •Corneal surgery in the last 12 months
- •Glaucoma with pressure above 25 mmHg in the last three months.
- •Best Correct Visual Acuity below 1/10 in at least one eye.
Outcomes
Primary Outcomes
Retinal pigment epithelium changes in Retinitis Pigmentosa.
Time Frame: 14 months
Retinal pigment epithelium extent measured with OCT calliper (micrometers).
Secondary Outcomes
- Retinitis Pigmentosa biomarkers(14 months)