Clinical trial NCT05320172: Platelet Rich Plasma in Corneal Surface Diseases
Official title: Effect of Platelet Rich Plasma Eye Drops in Corneal Surface Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Persistent Corneal Epithelial Defects
Dry Eye
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: At 48 hours, one week and one month.
measure: 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.
timeFrame: At 48 hours, one week and one month.
measure: 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,
timeFrame: At 48 hours, one week and one month.
Secondary outcomes:
measure: 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.
timeFrame: At 48 hours, one week and one month.
Other outcomes:
Locations:
Study officials:
affiliation: Professor of ophthalmology, Faculty of medicine, Assiut University
name: Mohamed S Abdelrahman, MD
role: STUDY_CHAIR
affiliation: Assistant professor of ophthalmology, Faculty of medicine, Assiut University
name: Mahmoud F Rateb, MD
role: STUDY_CHAIR
affiliation: Lecturer of ophthalmology, Faculty of medicine, Assiut university
name: Mohamed G Saleh, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.