Clinical trial

Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions

Name

Anita Syla 1983

Description

Platelet-rich plasma (PRP) is an autologous blood product rich in proteins and growth factors. Its application has been the subject of many studies in the field of ophthalmology to stimulate tissue healing and regeneration. Due to its anatomical features (lack of blood vessels), the cornea is among the most susceptible to damage structures of the eye. Therefore, the study of the impact of various regenerative therapies (autologous blood products, serums, ) on corneal lesions is important not only scientifically, but also practically for ophthalmologist. Numerous reports described the healing effect of PRP on corneal lesions.

Trial arms

Trial start

2021-09-01

Estimated PCD

2023-09-01

Trial end

2024-09-01

Treatment

PRP plasma rich platelets

Twenty patients (20) underwent 0.5 ml 100 % intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month

Arms:

PRP -plasma rich platelets group

Other names:

PRP

Autologous serum

Twenty patients (20) underwent intrastromal injection of 0.5 ml 100 %of autologous serum (second group) every 2 weeks for 1 month

Arms:

Autologous serum group

Other names:

Size

Primary endpoint

Improving dry eye symptoms

12 months

Eligibility criteria

Inclusion Criteria: * Dry eye diseases from other conditions( diabetes,allergy,keratoconus and others) * Corneal dystrophy * Chemical burns * Keratoconus Exclusion Criteria: * Hemoglobin saturation (less than 11 mg/dl); * hepatopathies; * nephropathies; * coagulopathies; * hemoglobinopathies; * decompensated heart diseases; * infectious diseases such as Chagas, syphilis, HIV, HTLV, hepatitis B and C, and others transmissible by blood considered.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Both models participated in this study.Models aged were from 20 up to 70', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-07-13

1 organization

2 products

1 indication

Organization

Product

Indication

Product