An interventional study of PRP plasma rich platelets and Autologous serum in PRP, sponsored by Anita Syla Lokaj. Enrolling by invitation at 1 site in Kosovo. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Anita Syla Lokaj · Not applicable, Interventional, and Treatment
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.
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Anita Syla Lokaj as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 intrastromal injection of 0.5 ml of autologous serum (second group) every 2 weeks for 1 month
Drug: Autologous serum
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
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
Improving dry eye symptoms
hange From Baseline in Ocular Surface Staining \[
Time frame: 12 months
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.
Time frame: 12 months
Plan to share: No
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Studies of the drug tested here: Platelet rich plasma