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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Corneal Epithelial Defects

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).
  2. Dry eye disease.

Exclusion Criteria:

  1. Active ocular infection or inflammation.
  2. Patients will be withdrawn if allergic or adverse side effects develop.
  3. Pregnancy or breast feeding.
  4. The use of systemic antiplatelet or anticoagulant.
  5. Uncontrolled systemic diseases
  6. Non-compliance with the study protocol.
  7. Positive HIV, HBV, HCB or Syphilis.
  8. 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

    First Posted
    November 16, 2021
    Last Updated
    February 24, 2023
    Sponsor
    Assiut University
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    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

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