跳至主要内容
临床试验/NCT06200727
NCT06200727进行中(未招募)不适用

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

Lei Du1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
170
试验地点
1
主要终点
Whether the macular hole is closed in participants with macular hole(Unit: yes/no)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

PRF membrane in macular hole

Experimental

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.

干预措施: PRF membrane tamponade surgery in macular hole (Procedure)

Internal limmiting membrane(ILM) peeling in macular hole

Active Comparator

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.

干预措施: ILM peeling in macular hole (Procedure)

PRF membrane transplantation in pterygium

Experimental

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.

干预措施: PRF membrane grafting in pterygium (Procedure)

Autologous conjunctival transplantation in pterygium

Active Comparator

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.

干预措施: Autologous conjunctival transplantation in pterygium (Procedure)

PRF membrane transplantation in trabeculectomy for glaucoma

Experimental

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.

干预措施: autologous PRF membrane grafting in trabeculectomy for glaucoma (Procedure)

Amniotic membrane in trabeculectomy for glaucoma

Active Comparator

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.

干预措施: Amniotic membrane in trabeculectomy for glaucoma (Procedure)

PRF membrane transplantation in corneal ulcer

Experimental

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.

干预措施: PRF membrane grafting incorneal ulcer (Procedure)

Amniotic membrane in corneal ulcer

Active Comparator

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.

干预措施: Amniotic membrane in corneal ulcer (Procedure)

结局指标

主要结局

Whether the macular hole is closed in participants with macular hole(Unit: yes/no)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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.)
  • 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.)
  • 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.)
  • Occurrence of complications in participants with pterygium(Unit: rate)(Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.)

研究者

发起方
Lei Du
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lei Du

deputy chief physician

Renmin Hospital of Wuhan University

研究点 (1)

Loading locations...

相似试验

Platelet-rich Fibrin(PRF) Membrane in Ophthalmic... | 临床试验