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

NCT05944757 | Unknown

• 1 other identifier: Anita Syla 1983
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PRP

Keywords

PRP; Dry Eye; Keratoconus; Dystrophy; Regenerative therapy

Outcome Measures

Primary Outcomes (1)

• Improving dry eye symptoms

  hange From Baseline in Ocular Surface Staining \[

  12 months

Secondary Outcomes (1)

• Improving corneal transparency

  12 months

Study Arms (2)

PRP -plasma rich platelets group

EXPERIMENTAL

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

Drug: PRP plasma rich platelets

Autologous serum group

ACTIVE COMPARATOR

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

Drug: Autologous serum

Interventions

PRP plasma rich platelets DRUG

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

Also known as: PRP

PRP -plasma rich platelets group

Autologous serum DRUG

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

Also known as: AS

Autologous serum group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dry eye diseases from other conditions( diabetes,allergy,keratoconus and others)
• Corneal dystrophy
• Chemical burns
• Keratoconus

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anita Syla Lokaj: lead

Study Sites (1)

Eye Hospital,University Center Clinic of Kosova

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Corneal Diseases

Study Officials

• Anita Syla Lokaj

  Eye Hospital,Univeristy Center Clinic of Kosova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator Faruk Semiz

Model Details: Both models participated in this study.Models aged were from 20 up to 70

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: July 13, 2023
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)