Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice
About this trial
The investigatror wants to show the efficacy of Platelet-Rich Plasma injection in lacrimal gland to restore the lacrimal secretion in patients presenting aqueous deficiency reponsible for severe dry eye syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Platelet counts, and clotting factors in the standarts
Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist
Disqualifiers
Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
Patients with complete stenosis of both lacrimal meatus in the treated eye
Trial design
Design model
Single group
Treatments tested in this trial
injections of Platelet-Rich Plasma in lacrimal gland
Other interventioninjections of Platelet-Rich Plasma in lacrimal gland
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Injection of Platelet-Rich Plasma (PRP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
Schirmer I test score between 0mm and more 20mm
Time frame
week 16Secondary outcomes
1
To compare the different clinical follow-up parameters of qualitative dry ocular syndrome and quantitative after 4 monthly injections of PRP into the lacrimal gland
Ocular Surface Diseases Index (OSDI) a scale of 0 to 100
Time frame
week 16Sponsors and contacts
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Source ClinicalTrials.gov