Platelet-rich FibrinNCT06200727

Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

A study testing PRF membrane tamponade surgery in macular hole, ILM peeling in macular hole and PRF membrane grafting in pterygium in people with Platelet-rich Fibrin and Macular Holes, run by Lei Du at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 20 to 90 years
Conditions the study is for: Platelet-rich Fibrin, Macular Holes, Pterygium
What is being tested?: PRF membrane tamponade surgery in macular hole, ILM peeling in macular hole and PRF membrane grafting in pterygium
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteChina
Study dates: 1 Jan 2023to 31 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Platelet-rich Fibrin, Macular Holes, Pterygium, Glaucoma
Being tested: PRF membrane tamponade surgery in macular hole, ILM peeling in macular hole, PRF membrane grafting in pterygium, Autologous conjunctival transplantation in pterygium, autologous PRF membrane grafting in trabeculectomy for glaucoma
Keywords: PRF; pterygium; macular hole; corneal ulcer
Medical subject headings: Retinal Perforations, Pterygium, Glaucoma, Corneal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRF membrane tamponade surgery in macular holeProcedure or surgery
A specially formulated PRF membrane, as described previously, was filled into the macular hole to promote fissure repair.
ILM peeling in macular holeProcedure or surgery
The treatment of the macular hole was ILM peeling.
PRF membrane grafting in pterygiumProcedure or surgery
Used of autologous PRF membrane to cover the exposed conjunctiva after pterygium excision.
Autologous conjunctival transplantation in pterygiumProcedure or surgery
Used of autologous conjunctiva to cover exposed sclera after pterygium excision
autologous PRF membrane grafting in trabeculectomy for glaucomaProcedure or surgery
Used of autologous PRF membranes to cover the exposed sclera after trabeculectomy for glaucoma.
Amniotic membrane in trabeculectomy for glaucomaProcedure or surgery
Used of amniotic to cover the exposed sclera after trabeculectomy for glaucoma.
PRF membrane grafting incorneal ulcerProcedure or surgery
After surgical debridement of corneal ulcers, autologous PRF membrane was placed over the corneal wound to promote corneal healing
Amniotic membrane in corneal ulcerProcedure or surgery
After surgical debridement of corneal ulcers, autologous amniotic membrane was placed over the corneal wound to promote corneal healing

Study groups in NCT06200727
Study group	Role	What they receive
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. Receives: Procedure: PRF membrane tamponade surgery in macular hole
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. Receives: Procedure: ILM peeling in macular hole
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. Receives: Procedure: PRF membrane grafting in pterygium
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. Receives: Procedure: Autologous conjunctival transplantation in pterygium
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. Receives: Procedure: autologous PRF membrane grafting in trabeculectomy for glaucoma
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. Receives: Procedure: Amniotic membrane in trabeculectomy for glaucoma
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. Receives: Procedure: PRF membrane grafting incorneal ulcer
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. Receives: Procedure: Amniotic membrane in corneal ulcer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202331 Dec 2025

First posted11 Jan 2024
Study start1 Jan 2023
Primary completion30 Jun 2025 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Platelet-rich FibrinStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 170 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06200727
Sponsor's protocol ID: WDRY2022-K197
Status last verified: Jan 2024
First submitted: 11 Dec 2023
Last updated: 12 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

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.
PubMed 34155746
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.
PubMed 35179414
Lu G, Zeng S, Huang R, Du L. Platelet-rich Fibrin Membrane Transplantation for the Treatment of Highly Myopic Macular Hole Retinal Detachment. Ophthalmol Ther. 2024 Sep;13(9):2425-2443. doi: 10.1007/s40123-024-00997-w. Epub 2024 Jul 26.
PubMed 39060701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Platelet-rich Fibrin trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases
ClinicalTrials.gov ID: NCT06200727
Acronym / sponsor ID: WDRY2022-K197
Conditions: Platelet-rich Fibrin, Macular Holes, Pterygium, Glaucoma
Keywords: PRF; pterygium; macular hole; corneal ulcer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 170 participants (estimated)
Lead sponsor: Lei DuUniversity, hospital or other
Study start: 1 Jan 2023 (actual)
Primary completion: 30 Jun 2025 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 11 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
PRF membrane in macular hole	Experimental	Procedure: PRF membrane tamponade surgery in macular holeTo 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.
Internal limmiting membrane(ILM) peeling in macular hole	Active comparator	Procedure: ILM peeling in macular holeAfter 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.
PRF membrane transplantation in pterygium	Experimental	Procedure: PRF membrane grafting in pterygiumFollowing 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.
Autologous conjunctival transplantation in pterygium	Active comparator	Procedure: Autologous conjunctival transplantation in pterygiumAfter 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.
PRF membrane transplantation in trabeculectomy for glaucoma	Experimental	Procedure: autologous PRF membrane grafting in trabeculectomy for glaucomaThe 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.
Amniotic membrane in trabeculectomy for glaucoma	Active comparator	Procedure: Amniotic membrane in trabeculectomy for glaucomaThe 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.
PRF membrane transplantation in corneal ulcer	Experimental	Procedure: PRF membrane grafting incorneal ulcerThe 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.
Amniotic membrane in corneal ulcer	Active comparator	Procedure: Amniotic membrane in corneal ulcerThe 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.

Who may qualify

Ages: 20 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRF membrane tamponade surgery in macular holeA specially formulated PRF membrane, as described previously, was filled into the macular hole to promote fissure repair.	Procedure or surgery	PRF membrane in macular hole
ILM peeling in macular holeThe treatment of the macular hole was ILM peeling.	Procedure or surgery	Internal limmiting membrane(ILM) peeling in macular hole
PRF membrane grafting in pterygiumUsed of autologous PRF membrane to cover the exposed conjunctiva after pterygium excision.	Procedure or surgery	PRF membrane transplantation in pterygium
Autologous conjunctival transplantation in pterygiumUsed of autologous conjunctiva to cover exposed sclera after pterygium excision	Procedure or surgery	Autologous conjunctival transplantation in pterygium
autologous PRF membrane grafting in trabeculectomy for glaucomaUsed of autologous PRF membranes to cover the exposed sclera after trabeculectomy for glaucoma.	Procedure or surgery	PRF membrane transplantation in trabeculectomy for glaucoma
Amniotic membrane in trabeculectomy for glaucomaUsed of amniotic to cover the exposed sclera after trabeculectomy for glaucoma.	Procedure or surgery	Amniotic membrane in trabeculectomy for glaucoma
PRF membrane grafting incorneal ulcerAfter surgical debridement of corneal ulcers, autologous PRF membrane was placed over the corneal wound to promote corneal healing	Procedure or surgery	PRF membrane transplantation in corneal ulcer
Amniotic membrane in corneal ulcerAfter surgical debridement of corneal ulcers, autologous amniotic membrane was placed over the corneal wound to promote corneal healing	Procedure or surgery	Amniotic membrane in corneal ulcer

Primary outcome

Whether the macular hole is closed in participants with macular hole(Unit: yes/no)
Time frame: 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 wound heals completely after pterygium excision in participants with pterygium(Unit: yes/no)
Time frame: 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)
Time frame: 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.
Whether the corneal ulcer is healing in participants with corneal ulcer(Unit: yes/no)
Time frame: 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.

4 secondary outcomes

Best-corrected visual acuity (BCVA) in participants with macular hole(Unit: logMAR)
Time frame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.
Occurrence of complications in participants with pterygium(Unit: rate)
Time frame: 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)
Time frame: 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)
Time frame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Background: PubMed 34155746Yang 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.
Results publication: PubMed 35179414Yang 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.
Derived from this study: PubMed 39060701Lu G, Zeng S, Huang R, Du L. Platelet-rich Fibrin Membrane Transplantation for the Treatment of Highly Myopic Macular Hole Retinal Detachment. Ophthalmol Ther. 2024 Sep;13(9):2425-2443. doi: 10.1007/s40123-024-00997-w. Epub 2024 Jul 26.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lei Du principal investigator

Renmin Hospital of Wuhan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whether the macular hole is closed in participants with macular hole(Unit: yes/no) (time frame: Pre-operation, and at 1 week, 1 month, 3 months, and 6 months post-operation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200727, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.