Platelet Rich Plasma in Corneal Surface Diseases

NCT05320172 | Unknown Phase 3

• 1 other identifier: PRP ED in corneal diseases
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Persistent Corneal Epithelial Defects; Dry Eye

Outcome Measures

Primary Outcomes (3)

• 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.

  At 48 hours, one week and one month.

• 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.

  At 48 hours, one week and one month.

• 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.

  At 48 hours, one week and one month.

Secondary Outcomes (1)

• 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.

  At 48 hours, one week and one month.

Study Arms (1)

Treatment group

EXPERIMENTAL

Participants with persistent epithelial defects will be treated with autologous platelet rich plasma eye drops.

Drug: Autologous platelet rich plasma eye drops

Interventions

Autologous platelet rich plasma eye drops DRUG

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.

Also known as: PRP eye drops

Treatment group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 22972393 RESULT

• 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.

  PMID: 15090417 RESULT

• 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.

  PMID: 21740369 RESULT

• 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.

  PMID: 17324465 RESULT

• 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.

  PMID: 21479340 RESULT

• 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.

  PMID: 27051257 RESULT

• 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.

  PMID: 29018685 RESULT

Related Links

• Eye platelet-rich plasma in the treatment of ocular surface disorders
• Platelet-Rich Plasma (PRP): What Is PRP and What Is Not PRP? Marx, Robert E. DDS
• Treatment of Dry Eye Disease with Autologous Platelet-Rich Plasma

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Mohamed S Abdelrahman, MD

  Professor of ophthalmology, Faculty of medicine, Assiut University

  STUDY CHAIR

• Mahmoud F Rateb, MD

  Assistant professor of ophthalmology, Faculty of medicine, Assiut University

  STUDY CHAIR

• Mohamed G Saleh, MD

  Lecturer of ophthalmology, Faculty of medicine, Assiut university

  STUDY DIRECTOR

Central Study Contacts

Ahmed A Abdelnasser

CONTACT

01099427763; ahmedazzam200@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Resident, Assiut University Hospital

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: April 11, 2022
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share