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Clinical Trials/NCT06831253
NCT06831253RecruitingNot Applicable

Efficacy of Restoration of Lacrimal Secretion After Injection of Platelet-Rich Plasma (PRP) Into the Lacrimal Gland in Severe Dry Eye Syndromes (ReLIPSSO)

Centre Hospitalier Universitaire de Nice1 site in 1 country20 target enrollmentStarted: March 17, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

To assess the lacrimal secretion after 4 injections of PRP in lacrimal gland

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Injection of Platelet-Rich Plasma (PRP)

Experimental

Intervention: injections of Platelet-Rich Plasma in lacrimal gland (Other)

Outcomes

Primary Outcomes

To compare the lacrimal secretion after 4 monthly injections of PRP into the lacrimal gland

Time Frame: week 16

Schirmer I test score between 0mm and more 20mm

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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