Back to resultsCompare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions (prp)
Primary Purpose
PRP
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
PRP plasma rich platelets
Autologous serum
Sponsored by
About this trial
This is an interventional treatment trial for PRP focused on measuring PRP, Dry Eye, Keratoconus, Dystrophy, Regenerative therapy
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.
Sites / Locations
- Eye Hospital,University Center Clinic of Kosova
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRP -plasma rich platelets group
Autologous serum group
Arm Description
Twenty patients (20) underwent 0.5 ml intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month
Twenty patients (20) underwent intrastromal injection of 0.5 ml of autologous serum (second group) every 2 weeks for 1 month
Outcomes
Primary Outcome Measures
Improving dry eye symptoms
hange From Baseline in Ocular Surface Staining [
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05944757
Brief Title
Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
Acronym
prp
Official Title
Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anita Syla Lokaj
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRP
Keywords
PRP, Dry Eye, Keratoconus, Dystrophy, Regenerative therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both models participated in this study.Models aged were from 20 up to 70
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRP -plasma rich platelets group
Arm Type
Experimental
Arm Description
Twenty patients (20) underwent 0.5 ml intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month
Arm Title
Autologous serum group
Arm Type
Active Comparator
Arm Description
Twenty patients (20) underwent intrastromal injection of 0.5 ml of autologous serum (second group) every 2 weeks for 1 month
Intervention Type
Drug
Intervention Name(s)
PRP plasma rich platelets
Other Intervention Name(s)
PRP
Intervention Description
Twenty patients (20) underwent 0.5 ml 100 % intrastromal injection of PRP plasma rich platelets (first group) every 2 weeks for one month
Intervention Type
Drug
Intervention Name(s)
Autologous serum
Other Intervention Name(s)
AS
Intervention Description
Twenty patients (20) underwent intrastromal injection of 0.5 ml 100 %of autologous serum (second group) every 2 weeks for 1 month
Primary Outcome Measure Information:
Title
Improving dry eye symptoms
Description
hange From Baseline in Ocular Surface Staining [
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improving corneal transparency
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Syla Lokaj
Organizational Affiliation
Eye Hospital,Univeristy Center Clinic of Kosova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital,University Center Clinic of Kosova
City
Prishtina
ZIP/Postal Code
10000
Country
Kosovo
12. IPD Sharing Statement
Plan to Share IPD
No
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Compare of PRP Autologous Serum and Autologous Serum by Intrastromal Injection in Different Eye Disease Conditions
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