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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PRP
• Intervention / Treatment: Drug: PRP plasma rich platelets; Drug: Autologous serum

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kosovo
  • Prishtina, Kosovo, 10000
    • Eye Hospital,University Center Clinic of Kosova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP -plasma rich platelets group; 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; Twenty patients (20) underwent 0.5 ml 100 % intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month; Other Names: PRP
Active Comparator: Autologous serum group; Twenty patients (20) underwent intrastromal injection of 0.5 ml of autologous serum (second group) every 2 weeks for 1 month	Drug: Autologous serum; Twenty patients (20) underwent intrastromal injection of 0.5 ml 100 %of autologous serum (second group) every 2 weeks for 1 month; Other Names: AS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving dry eye symptoms	hange From Baseline in Ocular Surface Staining [	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving corneal transparency	Change From Baseline in Ocular Surface Disease Index (OSDI) The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye. The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.	12 months

Collaborators and Investigators

• Sponsor: Anita Syla Lokaj
• Investigators: Principal Investigator: Anita Syla Lokaj, Eye Hospital,Univeristy Center Clinic of Kosova

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 27, 2022
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Dry Eye; Keratoconus; PRP; Dystrophy; Regenerative therapy
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: Anita Syla 1983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No