Melatonin effects on visual and sleep patterns anomalies in subjects diagnosed with Retinitis Pigmentosa

• Conditions: To evaluate the sleep quality in patients with Retinitis Pigmentosa; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-002436-82-ES
• Lead Sponsor: Isabel Pinilla Lozano

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-22
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a)Patients from de Ophthalmology Department
b)Being 18 years old or older
c)Diagnosed with Retinitis Pigmentosa
d)Visual acuity equal or less than 20/200
e) In case of any other pathologies, treated with the standard treatment following the international directions and the protocols established by the Ophthalmic Unit
f)Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) No informed consent
b) Absence of other ophthalmological treatments if needed
c) Patients affected by atypical forms of Retinitis Pigmentosa as sector or paravenous forms, Bardet Biedl or Refsum syndromes, or Retinitis punctata albescens.
d) Patients with other systemic pathologies or deafness (excluding Usher syndrome)
e) Pregnancy (or a likelihood of becoming pregnant) or lactation.
f) Patients with other retinal diseases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified