Clinical trial NCT06200727: Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases
Official title: Application of Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Platelet-rich Fibrin
Macular Holes
Pterygium
Glaucoma
Keywords: PRF; pterygium; macular hole; corneal ulcer
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 170
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Whether the macular hole is closed in participants with macular hole(Unit: yes/no)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
measure: Whether the wound heals completely after pterygium excision in participants with pterygium(Unit: yes/no)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
measure: IOP in participants undergoing trabeculectomy for glaucoma(Unit: mmHg)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
measure: Whether the corneal ulcer is healing in participants with corneal ulcer(Unit: yes/no)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Secondary outcomes:
measure: Best-corrected visual acuity (BCVA) in participants with macular hole(Unit: logMAR)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
measure: Occurrence of complications in participants with pterygium(Unit: rate)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
measure: Degree of tissue scarification in participants undergoing trabeculectomy for glaucoma(Unit: mild, moderate, severe)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
measure: Occurrence of complications in participants with corneal ulcer(Unit: rate)
timeFrame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Eye Center, Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Lei Du
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.