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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05944757
Acronym
prp
Enrollment
40
Registered
2023-07-13
Start date
2021-09-01
Completion date
2024-09-01
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PRP

Keywords

PRP, Dry Eye, Keratoconus, Dystrophy, Regenerative therapy

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.

Interventions

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

Sponsors

Anita Syla Lokaj
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improving dry eye symptoms12 monthshange From Baseline in Ocular Surface Staining \[

Secondary

MeasureTime frameDescription
Improving corneal transparency12 monthsChange 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.

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026