Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome

Not Applicable

Recruiting

• Conditions: Severe Dry Eye Syndromes; Dry Eye Syndromes

• Registration Number: NCT06831253
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

injections in lacrimal gland four times during the study for each patient

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-18
• Status Verified: 2025-03
• Study Start: 2025-03-17
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-03-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Platelet counts, and clotting factors in the standarts
• Presenting with severe dry keratoconjunctivitis diagnosed by an ophthalmologist

Exclusion Criteria

• Patients with significant fibrosis of the conjunctival portion of the lacrimal gland
• Patients with complete stenosis of both lacrimal meatus in the treated eye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland	week 16	Schirmer I test score between 0mm and more 20mm

Secondary Outcome Measures

Name	Time	Method
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	week 16	Ocular Surface Diseases Index (OSDI) a scale of 0 to 100

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Site Principal Investigator, France