About this trial
The aim of this study is to determine whether 9-cis-beta Caroten rich D. Brdawiil extract is effective in the treatment of retinitis pigmentosa in adolescent patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent to participate in the study.
Adolescent 12-18 years old.
Electroretinogram (ERG) responses compatible with the diagnosis of Retinitis Pigmentosa
Disqualifiers
Currently a smoker
Current use of vitamin A/ β-carotene supplements
Active arterial disease within 3 months prior to enrolment in the study, e.g. unstable angina, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass graft surgery
History of malignancy, excepting basal or squamous cell skin carcinoma
Trial design
Crossover
Treatments tested in this trial
Alga Dunaliella Bardawil powder
Dietary supplement9 cis beta carotene rich Alga Dunaliella Bardawil powder
Placebo:Starch
Dietary supplementStarch powder
Treatment groups
Trial outcomes
Primary outcomes
Mean binocular maximal scotopic electroretinogram b-wave response
Using the protocol of the International Society for Clinical Electrophysiology of Vision and the "UTAS 3000" system (LKC Technologies, Gaithersburg, MD), full-field electroretinographic responses will be recorded from both eyes of each patient. For scotopic conditions, maximal ERG b-wave responses will be recorded following 30 minutes of dark adaptation.
Secondary outcomes
The area within the Dark adapted chromatic Goldamann Visual field in isopters in cm2
Kinetic visual field for chromatic stimuli will be recorded in both eyes after 30 minutes of dark adaptation. Area of vision within the isopter will be measured by software in cm2.
The area within Goldamann Visual field in isopters in cm2
Kinetic visual field will be recorded in both eyes. Area of vision within the isopter will be measured by software in cm2.
Mean binocular maximal photopic electroretinogram b-wave response
Using the protocol of the International Society for Clinical Electrophysiology of Vision and the UTAS 3000 system (LKC Technologies, Gaithersburg, MD), full-field photopic electroretinographic responses will be recorded from both eyes of each patient.
Best-corrected visual acuity (EDTRS)
Sponsors and contacts
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