Actively Recruiting
Efficacy of Restoration of Lacrimal Secretion After Injection of Platelet-Rich Plasma Into the Lacrimal Gland in Severe Dry Eye Syndromes
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-19
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Platelet-Rich Plasma (PRP) injections into the lacrimal gland to help restore tear production in patients with severe dry eye syndrome caused by aqueous deficiency. The study focuses on patients diagnosed with severe dry keratoconjunctivitis, aiming to assess how PRP may improve lacrimal secretion and relieve symptoms associated with dry eyes. Participants will receive four injections of PRP directly into the lacrimal gland, administered once a month during the study period. This approach is being studied to determine whether repeated PRP injections can enhance tear production and improve clinical signs of dry eye syndrome. During the study, researchers will monitor lacrimal secretion levels and various clinical parameters related to both the quality and quantity of tears after the four monthly PRP injections. The primary outcome is to compare tear production at week 16, with additional follow-up assessments to evaluate the overall improvement in dry eye symptoms. Participants will be observed throughout the study to track these outcomes and ensure safety.
CONDITIONS
Brief Title
Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Platelet counts and clotting factors must be within standard ranges
- Diagnosed with severe dry keratoconjunctivitis by an ophthalmologist
You will not qualify if you...
- Significant fibrosis of the conjunctival portion of the lacrimal gland
- Complete stenosis (blockage) of both lacrimal meatus in the treated eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 16 weeks
Participants receive four injections of Platelet-Rich Plasma into the lacrimal gland over the course of the study.
4 injections, approximately 1 per month
Trial Site Locations
Total: 1 location
1
CHU de Nice
Nice, Site Principal Investigator, France, 06000
Actively Recruiting
Research Team
D
Doctor Jean Philippe GROSSE, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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