Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

Not Applicable

Active, not recruiting

• Conditions: Platelet-rich Fibrin; Pterygium; Glaucoma; Macular Holes

• Registration Number: NCT06200727
• Lead Sponsor: Lei Du

Brief 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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-30
• Status Verified: 2024-01
• Study First Posted: 2024-01-11
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Diagnosis of macular hole confirmed by fundus examination;
2. Diagnosis of pterygium by slit lamp;
3. Patients requiring trabeculectomy for glaucoma;
4. Diagnosis of corneal ulcer confirmed by slit lamp.

Exclusion Criteria

1. Combination of other active ophthalmic diseases, such as acute conjunctivitis and uveitis;
2. Previous history of ophthalmic trauma and ophthalmic surgery;
3. Recent use of anticoagulant or antiplatelet drugs;
4. Combination of serious systemic diseases such as hypertension and diabetes mellitus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Whether the macular hole is closed in participants with macular hole(Unit: yes/no)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Using optical coherence tomography（OCT ）to see if the macular hole is healing to compare the healing rate between the PRF membrane filling group and the ILM peeling group.
Whether the corneal ulcer is healing in participants with corneal ulcer(Unit: yes/no)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	The investigators use a slit lamp to examine the anterior segment of the eye to assess the corneal wound healing rate. The PRF membrane-covered group is compared to the control group.
Whether the wound heals completely after pterygium excision in participants with pterygium(Unit: yes/no)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Observation of the anterior segment of the eye using a slit lamp to determine whether the wound is healed after pterygium excision and to compare the healing rate between the PRF membrane-covered group and the autologous conjunctival-covered group.
IOP in participants undergoing trabeculectomy for glaucoma(Unit: mmHg)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Measurement of IOP using an IOP meter to compare the effect of IOP reduction in glaucoma treatment in the PRF membrane group and the amniotic membrane group.

Secondary Outcome Measures

Name	Time	Method
Degree of tissue scarification in participants undergoing trabeculectomy for glaucoma(Unit: mild, moderate, severe)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Viewing the anterior segment of the eye using a slit lamp to determine the extent of tissue scarring in participants undergoing trabeculectomy for glaucoma.
Occurrence of complications in participants with corneal ulcer(Unit: rate)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Using a slit lamp, visualizing the anterior eye segment to detect complications in participants with corneal ulcer.
Best-corrected visual acuity (BCVA) in participants with macular hole(Unit: logMAR)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Measurement of BCVA in participants with macular holes using an international standard logarithmic visual acuity chart.
Occurrence of complications in participants with pterygium(Unit: rate)	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.	Using a slit lamp, visualizing the anterior eye segment to detect complications in participants with pterygium.

Trial Locations

Locations (1)

Eye Center, Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China