Platelet Rich Plasma in Corneal Surface Diseases

Assiut University

Status and phase: Not yet enrolling; Phase 3

Conditions: Dry Eye; Persistent Corneal Epithelial Defects

Treatments: Drug: Autologous platelet rich plasma eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT05320172

PRP ED in corneal diseases

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Treatment group

Experimental group

Description:

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

Treatment:

Drug: Autologous platelet rich plasma eye drops