Glaucoma Clinical Trial
Official title:
Application of Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases
Verified date | January 2024 |
Source | Renmin Hospital of Wuhan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Eye Center, Renmin Hospital of Wuhan University | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Lei Du |
China,
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
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. |
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