Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06200727
• Other study ID #: WDRY2022-K197
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Renmin Hospital of Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• ILM peeling in macular hole
The treatment of the macular hole was ILM peeling.
• PRF membrane grafting in pterygium
Used of autologous PRF membrane to cover the exposed conjunctiva after pterygium excision.
• Autologous conjunctival transplantation in pterygium
Used of autologous conjunctiva to cover exposed sclera after pterygium excision
• autologous PRF membrane grafting in trabeculectomy for glaucoma
Used of autologous PRF membranes to cover the exposed sclera after trabeculectomy for glaucoma.
• Amniotic membrane in trabeculectomy for glaucoma
Used of amniotic to cover the exposed sclera after trabeculectomy for glaucoma.
• PRF membrane grafting incorneal ulcer
After surgical debridement of corneal ulcers, autologous PRF membrane was placed over the corneal wound to promote corneal healing
• Amniotic membrane in corneal ulcer
After surgical debridement of corneal ulcers, autologous amniotic membrane was placed over the corneal wound to promote corneal healing

Locations

Country	Name	City	State
China	Eye Center, Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Lei Du

Country where clinical trial is conducted

China, 

References & Publications (2)

Yang N, Xing Y, Zhao Q, Zeng S, Yang J, Du L. Application of platelet-rich fibrin grafts following pterygium excision. Int J Clin Pract. 2021 Oct;75(10):e14560. doi: 10.1111/ijcp.14560. Epub 2021 Jul 5. — View Citation

Yang N, Zeng S, Yang J, Lu G, Du L. Application of Platelet-Rich Fibrin Transplantation for Large Macular Hole. Curr Eye Res. 2022 May;47(5):770-776. doi: 10.1080/02713683.2022.2029906. Epub 2022 Mar 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether the macular hole is closed in participants with macular hole(Unit: yes/no)	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.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Primary	Whether the wound heals completely after pterygium excision in participants with pterygium(Unit: yes/no)	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.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Primary	IOP in participants undergoing trabeculectomy for glaucoma(Unit: mmHg)	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.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Primary	Whether the corneal ulcer is healing in participants with corneal ulcer(Unit: yes/no)	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.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Secondary	Best-corrected visual acuity (BCVA) in participants with macular hole(Unit: logMAR)	Measurement of BCVA in participants with macular holes using an international standard logarithmic visual acuity chart.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Secondary	Occurrence of complications in participants with pterygium(Unit: rate)	Using a slit lamp, visualizing the anterior eye segment to detect complications in participants with pterygium.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Secondary	Degree of tissue scarification in participants undergoing trabeculectomy for glaucoma(Unit: mild, moderate, severe)	Viewing the anterior segment of the eye using a slit lamp to determine the extent of tissue scarring in participants undergoing trabeculectomy for glaucoma.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Secondary	Occurrence of complications in participants with corneal ulcer(Unit: rate)	Using a slit lamp, visualizing the anterior eye segment to detect complications in participants with corneal ulcer.	Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.