NCT06200727

Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

Application of Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Lei Du · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to observe the role of PRF in treating ophthalmic diseases.The efficacy and safety of PRF were validated for four ophthalmic conditions: macular hole, pterygium, corneal ulcer, and patients undergoing trabeculectomy for glaucoma. The main question aims to answer is PRF's effectiveness in ocular surface and fundus diseases. Participants will be divided into 2 groups, the experimental group will be treated with PRF and the control group will be treated with conventional surgery, with a 12-month postoperative follow-up to determine the role of PRF on wound healing in ophthalmic diseases.

Detailed description

Patients suffering from pterygium, macular hole, corneal ulcer, and glaucoma requiring for trabeculectomy , who visited Renmin Hospital of Whuhan University, were chosen to participate in this study. The participants were randomly divided into the experimental group (PRF group) and the control group (conventional group). The PRF group received PRF membrane treatment, while the conventional group received conventional surgical treatment. Before and after surgery, participants underwent a comprehensive ophthalmological exam at 1 week, 1 month, 3 months, 6 months, and 12 months. The outcome indicators are monitored and can vary depending on the disease. Participants with pterygium were examined for graft dissolution and complications. Participants with macular hole were monitored for hole closure, visual acuity recovery, and retinal blood flow recovery. Participants with corneal ulcer were monitored for lesion healing and complications such as degree of corneal vascularization and opacity. Participants with glaucoma were monitored for postoperative intraocular pressure (IOP), degree of conjunctival leakage in the filtration zone, and degree of scarring in the filtration zone.

Conditions

• Platelet-rich Fibrin
• Macular Holes
• Pterygium
• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	PRF membrane tamponade surgery in macular hole	A specially formulated PRF membrane, as described previously, was filled into the macular hole to promote fissure repair.
PROCEDURE	ILM peeling in macular hole	The treatment of the macular hole was ILM peeling.
PROCEDURE	PRF membrane grafting in pterygium	Used of autologous PRF membrane to cover the exposed conjunctiva after pterygium excision.
PROCEDURE	Autologous conjunctival transplantation in pterygium	Used of autologous conjunctiva to cover exposed sclera after pterygium excision
PROCEDURE	autologous PRF membrane grafting in trabeculectomy for glaucoma	Used of autologous PRF membranes to cover the exposed sclera after trabeculectomy for glaucoma.
PROCEDURE	Amniotic membrane in trabeculectomy for glaucoma	Used of amniotic to cover the exposed sclera after trabeculectomy for glaucoma.
PROCEDURE	PRF membrane grafting incorneal ulcer	After surgical debridement of corneal ulcers, autologous PRF membrane was placed over the corneal wound to promote corneal healing
PROCEDURE	Amniotic membrane in corneal ulcer	After surgical debridement of corneal ulcers, autologous amniotic membrane was placed over the corneal wound to promote corneal healing

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-01-11
• Last updated: 2024-01-12

Locations

1 site across 1 country: China