Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma; Pterygium; Platelet-rich Fibrin; Macular Holes
• Intervention / Treatment: Procedure: PRF membrane tamponade surgery in macular hole; Procedure: ILM peeling in macular hole; Procedure: PRF membrane grafting in pterygium; Procedure: Autologous conjunctival transplantation in pterygium; Procedure: autologous PRF membrane grafting in trabeculectomy for glaucoma; Procedure: Amniotic membrane in trabeculectomy for glaucoma; Procedure: PRF membrane grafting incorneal ulcer; Procedure: Amniotic membrane in corneal ulcer

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 Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Eye Center, Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF membrane in macular hole; To observe the healing and visual recovery of a macular hole, the macular hole was filled with a PRF membrane. Before the participant went into the operating theatre, a blood sample was taken from the anterior elbow vein using a 5 ml tube without anticoagulants. The middle layer of blood after centrifugation was PRF. After retrobulbar anesthesia and removal of the posterior vitreous cortex. In the PRF group, PRF membrane was utilized to fill the macular hole after the ILM was peeled. Then the eyeball was filled with sterile air after adequate air-liquid exchange. At the end of the operation, tobramycin dexamethasone ophthalmic ointment was applied to the operated eye with pressure, and the participant was instructed to maintain a prone position for 7 days after the operation.	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.
Active Comparator: Internal limmiting membrane(ILM) peeling in macular hole; After retrobulbar anesthesia and removal of the posterior vitreous cortex, the control group underwent the procedure of peeling the ILM. The ILM was completely removed from the retina. Then the eyeballs were filled with sterile air after adequate air-liquid exchange. At the end of the operation, tobramycin dexamethasone ophthalmic ointment was applied to the operated eye with pressure, and the participant was instructed to maintain a prone position for 7 days after the operation.	Procedure: ILM peeling in macular hole; The treatment of the macular hole was ILM peeling.
Experimental: PRF membrane transplantation in pterygium; Following the removal of the pterygium, the prepared PRF was cut to match the size of the exposed scleral surface. It was then placed on the sclera and secured to the surrounding conjunctiva using 3-7 interrupted sutures of 10-0 nylon thread. This was done to ensure that the PRF implant was perfectly aligned with the conjunctiva.	Procedure: PRF membrane grafting in pterygium; Used of autologous PRF membrane to cover the exposed conjunctiva after pterygium excision.
Active Comparator: Autologous conjunctival transplantation in pterygium; After the pterygium removal surgery, to restore the eye, participants need to undergo a corneal limbal stem cell transplant. The transplanted stem cells should be the same size as the exposed scleral surface above the temporal part of the eye. When transferring the transplant, ensured that the corneal edge of the grafted conjunctival flap was positioned opposite to the cornea. Closed the flap to the peripheral conjunctiva with 3-7 interrupted sutures using 10-0 nylon thread. Fixed the conjunctival flap to the surrounding conjunctiva with sutures, and covered the sclera with the surrounding bulbar conjunctiva.	Procedure: Autologous conjunctival transplantation in pterygium; Used of autologous conjunctiva to cover exposed sclera after pterygium excision
Experimental: PRF membrane transplantation in trabeculectomy for glaucoma; The surgical procedure involved the creation of a scleral flap and conjunctiva in the usual manner. The subflap tissue was rinsed with balanced saline and then a small piece of tissue (measuring 1.5mm x 2mm) was removed from the inferior trabecular tissue of the scleral flap. In the corresponding position, peripheral iris excision was performed and the iris was rinsed to remove lost pigment in the vicinity of the incision. Once the orientation was verified, the PRF membrane was placed under the scleral flap.	Procedure: autologous PRF membrane grafting in trabeculectomy for glaucoma; Used of autologous PRF membranes to cover the exposed sclera after trabeculectomy for glaucoma.
Active Comparator: Amniotic membrane in trabeculectomy for glaucoma; The surgical procedure began with creating the scleral flap and conjunctiva in the usual manner. The sub flap tissue was then rinsed with balanced saline, and a piece of tissue measuring 1.5mm x 2mm was excised from the inferior trabecular tissue of the scleral flap. Next, peripheral iris excision was performed in the corresponding position and the iris was rinsed to remove pigment in the vicinity of the incision. To control the tension of the sutures, the amniotic membrane was placed under the scleral flap, followed by meticulous suturing of the conjunctival flap.	Procedure: Amniotic membrane in trabeculectomy for glaucoma; Used of amniotic to cover the exposed sclera after trabeculectomy for glaucoma.
Experimental: PRF membrane transplantation in corneal ulcer; The necrotic tissue of the corneal ulcer was cleared to expose the local fresh tissue, and the PRF group prepared PRF membrane and covered the surface of the test eye, and the autologous PRF membrane was continuously sutured to the corresponding surrounding tissues using 10-0 absorbable sutures so that the PRF membrane covered the entire portion of the lesion and was able to be anchored to it.	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
Active Comparator: Amniotic membrane in corneal ulcer; The necrotic tissue of the corneal ulcer was removed to reveal the fresh tissue in the area. After that, the excess amniotic membrane was carefully extracted and placed over the affected eye's surface. The membrane was then attached securely to the surrounding tissue using 10-0 absorbable sutures, covering the entire lesion and holding it in place for proper 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Lei Du
• Investigators: Principal Investigator: Lei Du, Renmin Hospital of Wuhan University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PRF; pterygium; macular hole; corneal ulcer
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Conjunctival Diseases; Retinal Perforations; Pterygium
• Other Study ID Numbers: WDRY2022-K197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a new technology and the information may be of commercial value to healthcare organisations and pharmaceutical companies. If this data is made public, it may result in other organisations or businesses gaining access to this information, which may affect the organisation's competitive advantage.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No