Platelet Rich Plasma in Corneal Surface Diseases
Primary Purpose
Persistent Corneal Epithelial Defects, Dry Eye
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Autologous platelet rich plasma eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Corneal Epithelial Defects
Eligibility Criteria
Inclusion Criteria:
- Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).
- Dry eye disease.
Exclusion Criteria:
- Active ocular infection or inflammation.
- Patients will be withdrawn if allergic or adverse side effects develop.
- Pregnancy or breast feeding.
- The use of systemic antiplatelet or anticoagulant.
- Uncontrolled systemic diseases
- Non-compliance with the study protocol.
- Positive HIV, HBV, HCB or Syphilis.
- Anemia (less than 10 g/dl of HGB, platelet count less than 105/ul).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Participants with persistent epithelial defects will be treated with autologous platelet rich plasma eye drops.
Outcomes
Primary Outcome Measures
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in size of defect over different periods of time.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in size of defect by fluorescein staining on slit lamp biomicroscopy.
The largest linear dimension of the epithelial defect and its largest possible perpendicular within the confines of the epithelial defect are measured in millimeters using a slit lamp.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in visual acuity.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in visual acuity measured by Snellen visual acuity (VA) testing.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in height of tear meniscus,
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in height of tear meniscus measured by slit lamp biomicroscopy.
Secondary Outcome Measures
Evaluation of the efficacy of platelet rich plasma eye drops in the relief symptoms caused by persistent corneal epithelial defects, and dry eye disease by observation of change in ocular symptoms.
Secondary outcome measurements include the change and improvement of subjective symptoms during treatment; particularly pain. assessed by visual analog score for pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05320172
Brief Title
Platelet Rich Plasma in Corneal Surface Diseases
Official Title
Effect of Platelet Rich Plasma Eye Drops in Corneal Surface Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The Aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the management of different corneal surface disorders.
PRP is a blood sample with a concentrated platelet count, and numerous growth factors that are associated with conjunctival and corneal wound healing process. which is an important advantage over other products. PRP eye drops recently are proving to be an effective and potent therapeutic approach to promote corneal wound re-epithelization and promote ocular surface regeneration in different pathological conditions.
Detailed Description
There are many conditions in which the ocular surface is severely affected as keratoconjunctivitis sicca, persistent epithelial corneal defect, recurrent corneal erosion, neurotrophic keratopathy, post laser in-situ keratomileusis (LASIK) ocular surface syndrome (OSS), dormant corneal ulcer, graft-versus-host disease, ocular cicatricial pemphigoid, and neurotrophic changes. If corneal wound healing does not occur promptly, it can lead to visual loss, severe scarring, infection and even corneal perforation, the treatment of ocular surface disorders has a multifactorial approach and conventional therapy is often not enough to solve the problem.
Platelet-rich plasma (PRP) is defined as a portion of the plasma fraction of autologous blood having a platelet concentration above baseline. They use a PRP device, concentrate platelets using a double centrifugation technique and activate PRP just when they are ready to use it. The final concentration is at least 1.000.000 platelets/ microliter. Therefore, it is an autologous concentration of platelets and growth factors.
An important reservoir of proteins and growth factors precipitating in haemostasis, tissue regeneration, immune response, and wound healing. Alpha granules of the platelets include over 30 biologically active substances such as platelet-derived growth factor, transforming growth factor b1 and b2 and insulin-like growth factor 1, vascular endothelial growth factor, epidermal cell growth factor, fibroblast growth factor 2, and insulin-like growth factor.
Eye platelet-rich plasma has a lubricating effect and has been effective in regenerating the ocular surface in cases of micropunctate keratitis, decreasing inflammation in patients suffering from dry eye and stimulating wound-healing processes in dormant corneal ulcers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Corneal Epithelial Defects, Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Fifty milliliters of whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Participants with persistent epithelial defects will be treated with autologous platelet rich plasma eye drops.
Intervention Type
Drug
Intervention Name(s)
Autologous platelet rich plasma eye drops
Other Intervention Name(s)
PRP eye drops
Intervention Description
Fifty milliliters of patient's own whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.
Primary Outcome Measure Information:
Title
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in size of defect over different periods of time.
Description
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in size of defect by fluorescein staining on slit lamp biomicroscopy.
The largest linear dimension of the epithelial defect and its largest possible perpendicular within the confines of the epithelial defect are measured in millimeters using a slit lamp.
Time Frame
At 48 hours, one week and one month.
Title
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in visual acuity.
Description
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in visual acuity measured by Snellen visual acuity (VA) testing.
Time Frame
At 48 hours, one week and one month.
Title
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in height of tear meniscus,
Description
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in height of tear meniscus measured by slit lamp biomicroscopy.
Time Frame
At 48 hours, one week and one month.
Secondary Outcome Measure Information:
Title
Evaluation of the efficacy of platelet rich plasma eye drops in the relief symptoms caused by persistent corneal epithelial defects, and dry eye disease by observation of change in ocular symptoms.
Description
Secondary outcome measurements include the change and improvement of subjective symptoms during treatment; particularly pain. assessed by visual analog score for pain.
Time Frame
At 48 hours, one week and one month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).
Dry eye disease.
Exclusion Criteria:
Active ocular infection or inflammation.
Patients will be withdrawn if allergic or adverse side effects develop.
Pregnancy or breast feeding.
The use of systemic antiplatelet or anticoagulant.
Uncontrolled systemic diseases
Non-compliance with the study protocol.
Positive HIV, HBV, HCB or Syphilis.
Anemia (less than 10 g/dl of HGB, platelet count less than 105/ul).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Abdelnasser
Phone
01099427763
Ext
+2
Email
ahmedazzam200@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelrahman, MD
Organizational Affiliation
Professor of ophthalmology, Faculty of medicine, Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmoud F Rateb, MD
Organizational Affiliation
Assistant professor of ophthalmology, Faculty of medicine, Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed G Saleh, MD
Organizational Affiliation
Lecturer of ophthalmology, Faculty of medicine, Assiut university
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22972393
Citation
Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.
Results Reference
result
PubMed Identifier
15090417
Citation
Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52. doi: 10.1136/bjo.2003.026211.
Results Reference
result
PubMed Identifier
21740369
Citation
Alio JL, Arnalich-Montiel F, Rodriguez AE. The role of "eye platelet rich plasma" (E-PRP) for wound healing in ophthalmology. Curr Pharm Biotechnol. 2012 Jun;13(7):1257-65. doi: 10.2174/138920112800624355.
Results Reference
result
PubMed Identifier
17324465
Citation
Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
Results Reference
result
PubMed Identifier
21479340
Citation
Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.
Results Reference
result
PubMed Identifier
27051257
Citation
Lee JH, Kim MJ, Ha SW, Kim HK. Autologous Platelet-rich Plasma Eye Drops in the Treatment of Recurrent Corneal Erosions. Korean J Ophthalmol. 2016 Apr;30(2):101-7. doi: 10.3341/kjo.2016.30.2.101. Epub 2016 Mar 25.
Results Reference
result
PubMed Identifier
29018685
Citation
Wu TE, Chen CJ, Hu CC, Cheng CK. Easy-to-prepare autologous platelet-rich plasma in the treatment of refractory corneal ulcers. Taiwan J Ophthalmol. 2015 Jul-Sep;5(3):132-135. doi: 10.1016/j.tjo.2014.09.001. Epub 2014 Nov 20.
Results Reference
result
Links:
URL
https://www.ophed.com/system/files/2015/07/Eye%20platelet-rich%20plasma%20in%20the%20treatment%20of%20ocular%20surface%20disorders.pdf?fbclid=IwAR3A7EUT-g_PraOMio5VqndyDA0i5h1SRQa35gKFtP7r4xqvX1hxr1YrP1g
Description
Eye platelet-rich plasma in the treatment of ocular surface disorders
URL
https://journals.lww.com/implantdent/Fulltext/2001/10000/Platelet_Rich_Plasma__PRP___What_Is_PRP_and_What.2.aspx
Description
Platelet-Rich Plasma (PRP): What Is PRP and What Is Not PRP? Marx, Robert E. DDS
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5693817/
Description
Treatment of Dry Eye Disease with Autologous Platelet-Rich Plasma
Learn more about this trial
Platelet Rich Plasma in Corneal Surface Diseases
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