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

Anita Syla Lokaj

Status: Invitation-only

Conditions: PRP

Treatments: Drug: Autologous serum; Drug: PRP plasma rich platelets

Study type: Interventional

Funder types: Other

Identifiers

NCT05944757

Anita Syla 1983

Details and patient eligibility

About

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.

Full description

Purpose The objective of the study is to compare the efficacy of 100% prp autolog serum eye drops with 100 % of intrastromal injection-rich plateles plasma autolog serum eye drops in patients with moderate to severe dry eye in keratoconus disease,corneal dystrophy,chemical burns.

Methods A total of 40 eyes were included in this prospective study. Clinical records of 20 consecutive patients with dry eye disease who had been treated with conventional autolog eye drops via intrastromal injection(conventional treatment group) and 20 consecutive patients treated with intrastromal autologous PRP eye drops i(PRP eye drops treated group) from September 2021.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

PRP -plasma rich platelets group

Experimental group

Description:

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

Treatment:

Drug: PRP plasma rich platelets

Autologous serum group

Active Comparator group

Description:

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

Treatment:

Drug: Autologous serum