Persistent Corneal Epithelial DefectsPhase 3NCT05320172
Platelet Rich Plasma in Corneal Surface Diseases
A Phase 3 study testing Autologous platelet rich plasma eye drops in people with Persistent Corneal Epithelial Defects and Dry Eye, run by Assiut University.
Trial summary
The Aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the management of different corneal surface disorders. PRP is a blood sample with a concentrated platelet count, and numerous growth factors that are associated with conjunctival and corneal wound healing process. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Persistent Corneal Epithelial Defects, Dry Eye
- What is being tested?
- Autologous platelet rich plasma eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Jun 2024
- Phase
- Phase 3
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).
- Dry eye disease.
Who cannot join
- Active ocular infection or inflammation.
- Patients will be withdrawn if allergic or adverse side effects develop.
- Pregnancy or breast feeding.
- The use of systemic antiplatelet or anticoagulant.
- Uncontrolled systemic diseases
- Non-compliance with the study protocol.
- Positive HIV, HBV, HCB or Syphilis.
- Anemia (less than 10 g/dl of HGB, platelet count less than 105/ul).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Platelet Rich Plasma Eye Drops in Corneal Surface Diseases
The Aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the management of different corneal surface disorders.
PRP is a blood sample with a concentrated platelet count, and numerous growth factors that are associated with conjunctival and corneal wound healing process. which is an important advantage over other products. PRP eye drops recently are proving to be an effective and potent therapeutic approach to promote corneal wound re-epithelization and promote ocular surface regeneration in different pathological conditions.
Read the detailed description
There are many conditions in which the ocular surface is severely affected as keratoconjunctivitis sicca, persistent epithelial corneal defect, recurrent corneal erosion, neurotrophic keratopathy, post laser in-situ keratomileusis (LASIK) ocular surface syndrome (OSS), dormant corneal ulcer, graft-versus-host disease, ocular cicatricial pemphigoid, and neurotrophic changes. If corneal wound healing does not occur promptly, it can lead to visual loss, severe scarring, infection and even corneal perforation, the treatment of ocular surface disorders has a multifactorial approach and conventional therapy is often not enough to solve the problem.
Platelet-rich plasma (PRP) is defined as a portion of the plasma fraction of autologous blood having a platelet concentration above baseline. They use a PRP device, concentrate platelets using a double centrifugation technique and activate PRP just when they are ready to use it. The final concentration is at least 1.000.000 platelets/ microliter. Therefore, it is an autologous concentration of platelets and growth factors.
An important reservoir of proteins and growth factors precipitating in haemostasis, tissue regeneration, immune response, and wound healing. Alpha granules of the platelets include over 30 biologically active substances such as platelet-derived growth factor, transforming growth factor b1 and b2 and insulin-like growth factor 1, vascular endothelial growth factor, epidermal cell growth factor, fibroblast growth factor 2, and insulin-like growth factor.
Eye platelet-rich plasma has a lubricating effect and has been effective in regenerating the ocular surface in cases of micropunctate keratitis, decreasing inflammation in patients suffering from dry eye and stimulating wound-healing processes in dormant corneal ulcers.
- Conditions
- Persistent Corneal Epithelial Defects, Dry Eye
- Being tested
- Autologous platelet rich plasma eye drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet rich plasma eye dropsDrug
Also called PRP eye drops
Fifty milliliters of patient's own whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants with persistent epithelial defects will be treated with autologous platelet rich plasma eye drops. Receives: Drug: Autologous platelet rich plasma eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in size of defect over different periods of time.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in size of defect by fluorescein staining on slit lamp biomicroscopy.
The largest linear dimension of the epithelial defect and its largest possible perpendicular within the confines of the epithelial defect are measured in millimeters using a slit lamp.
Measured: At 48 hours, one week and one month.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in visual acuity.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in visual acuity measured by Snellen visual acuity (VA) testing.
Measured: At 48 hours, one week and one month.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in height of tear meniscus,
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up.
Main outcome measurements include the change in height of tear meniscus measured by slit lamp biomicroscopy.
Measured: At 48 hours, one week and one month.
Secondary outcomes (1)
Evaluation of the efficacy of platelet rich plasma eye drops in the relief symptoms caused by persistent corneal epithelial defects, and dry eye disease by observation of change in ocular symptoms.
Secondary outcome measurements include the change and improvement of subjective symptoms during treatment; particularly pain. assessed by visual analog score for pain.
Measured: At 48 hours, one week and one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Persistent Corneal Epithelial DefectsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fifty milliliters of whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelnasser Mohamed Abdelnasser, Assiut University
- Investigators
- Mohamed S Abdelrahman, MD, Study chair, Professor of ophthalmology, Faculty of medicine, Assiut UniversityMahmoud F Rateb, MD, Study chair, Assistant professor of ophthalmology, Faculty of medicine, Assiut UniversityMohamed G Saleh, MD, Study director, Lecturer of ophthalmology, Faculty of medicine, Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320172
- Sponsor's protocol ID
- PRP ED in corneal diseases
- Status last verified
- Feb 2023
- First submitted
- 16 Nov 2021
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.
PubMed 22972393Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52. doi: 10.1136/bjo.2003.026211.
PubMed 15090417Alio JL, Arnalich-Montiel F, Rodriguez AE. The role of "eye platelet rich plasma" (E-PRP) for wound healing in ophthalmology. Curr Pharm Biotechnol. 2012 Jun;13(7):1257-65. doi: 10.2174/138920112800624355.
PubMed 21740369Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
PubMed 17324465Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.
PubMed 21479340Lee JH, Kim MJ, Ha SW, Kim HK. Autologous Platelet-rich Plasma Eye Drops in the Treatment of Recurrent Corneal Erosions. Korean J Ophthalmol. 2016 Apr;30(2):101-7. doi: 10.3341/kjo.2016.30.2.101. Epub 2016 Mar 25.
PubMed 27051257Wu TE, Chen CJ, Hu CC, Cheng CK. Easy-to-prepare autologous platelet-rich plasma in the treatment of refractory corneal ulcers. Taiwan J Ophthalmol. 2015 Jul-Sep;5(3):132-135. doi: 10.1016/j.tjo.2014.09.001. Epub 2014 Nov 20.
PubMed 29018685
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Rich Plasma Eye Drops in Corneal Surface Diseases
- ClinicalTrials.gov ID
- NCT05320172
- Acronym / sponsor ID
- PRP ED in corneal diseases
- Conditions
- Persistent Corneal Epithelial Defects, Dry Eye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 11 Apr 2022 (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.
The Aim of the study is to evaluate the efficacy of platelet rich plasma eye drops in the management of different corneal surface disorders.
PRP is a blood sample with a concentrated platelet count, and numerous growth factors that are associated with conjunctival and corneal wound healing process. which is an important advantage over other products. PRP eye drops recently are proving to be an effective and potent therapeutic approach to promote corneal wound re-epithelization and promote ocular surface regeneration in different pathological conditions.
Detailed description
There are many conditions in which the ocular surface is severely affected as keratoconjunctivitis sicca, persistent epithelial corneal defect, recurrent corneal erosion, neurotrophic keratopathy, post laser in-situ keratomileusis (LASIK) ocular surface syndrome (OSS), dormant corneal ulcer, graft-versus-host disease, ocular cicatricial pemphigoid, and neurotrophic changes. If corneal wound healing does not occur promptly, it can lead to visual loss, severe scarring, infection and even corneal perforation, the treatment of ocular surface disorders has a multifactorial approach and conventional therapy is often not enough to solve the problem.
Platelet-rich plasma (PRP) is defined as a portion of the plasma fraction of autologous blood having a platelet concentration above baseline. They use a PRP device, concentrate platelets using a double centrifugation technique and activate PRP just when they are ready to use it. The final concentration is at least 1.000.000 platelets/ microliter. Therefore, it is an autologous concentration of platelets and growth factors.
An important reservoir of proteins and growth factors precipitating in haemostasis, tissue regeneration, immune response, and wound healing. Alpha granules of the platelets include over 30 biologically active substances such as platelet-derived growth factor, transforming growth factor b1 and b2 and insulin-like growth factor 1, vascular endothelial growth factor, epidermal cell growth factor, fibroblast growth factor 2, and insulin-like growth factor.
Eye platelet-rich plasma has a lubricating effect and has been effective in regenerating the ocular surface in cases of micropunctate keratitis, decreasing inflammation in patients suffering from dry eye and stimulating wound-healing processes in dormant corneal ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fifty milliliters of whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Autologous platelet rich plasma eye dropsParticipants with persistent epithelial defects will be treated with autologous platelet rich plasma eye drops. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent epithelial defects (Exposure keratopathy, Post infectious keratitis).
- Dry eye disease.
Key exclusion criteria (8 listed)
- Active ocular infection or inflammation.
- Patients will be withdrawn if allergic or adverse side effects develop.
- Pregnancy or breast feeding.
- The use of systemic antiplatelet or anticoagulant.
- Uncontrolled systemic diseases
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 |
|---|---|---|
| Autologous platelet rich plasma eye dropsAlso: PRP eye dropsFifty milliliters of patient's own whole blood will be placed in five 10-ml vacutainer tubes containing anticoagulant-citrate-dextrose solution (1.4 ml) and centrifuged at 200g for 11 min. The upper two layers of the centrifuged blood, the plasma and buffy coat layer will be separated in a sterile manner and diluted to 20 % (v/v) with a sterile saline solution. The final preparation is divided into 5-ml bottles wrapped in aluminum foil for protection from ultraviolet light. The patients are instructed to store these bottles at -20 °C until required. The bottles being used will be maintained under refrigerated conditions at 4 °C. | Drug | Treatment group |
Primary outcome
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in size of defect over different periods of time.
Time frame: At 48 hours, one week and one month.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up. Main outcome measurements include the change in size of defect by fluorescein staining on slit lamp biomicroscopy. The largest linear dimension of the epithelial defect and its largest possible perpendicular within the confines of the epithelial defect are measured in millimeters using a slit lamp.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in visual acuity.
Time frame: At 48 hours, one week and one month.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up. Main outcome measurements include the change in visual acuity measured by Snellen visual acuity (VA) testing.
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in height of tear meniscus,
Time frame: At 48 hours, one week and one month.
To evaluate the effect of platelet-rich plasma (PRP) eye drops in management of different ocular surface pathologies, the therapeutic response will be evaluated with clinical examination and follow up. Main outcome measurements include the change in height of tear meniscus measured by slit lamp biomicroscopy.
1 secondary outcome
Evaluation of the efficacy of platelet rich plasma eye drops in the relief symptoms caused by persistent corneal epithelial defects, and dry eye disease by observation of change in ocular symptoms.
Time frame: At 48 hours, one week and one month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Results publication: PubMed 22972393Kim KM, Shin YT, Kim HK. Effect of autologous platelet-rich plasma on persistent corneal epithelial defect after infectious keratitis. Jpn J Ophthalmol. 2012 Nov;56(6):544-50. doi: 10.1007/s10384-012-0175-y. Epub 2012 Sep 13.
- Results publication: PubMed 15090417Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52. doi: 10.1136/bjo.2003.026211.
- Results publication: PubMed 21740369Alio JL, Arnalich-Montiel F, Rodriguez AE. The role of "eye platelet rich plasma" (E-PRP) for wound healing in ophthalmology. Curr Pharm Biotechnol. 2012 Jun;13(7):1257-65. doi: 10.2174/138920112800624355.
- Results publication: PubMed 17324465Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
- Results publication: PubMed 21479340Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.
- Results publication: PubMed 27051257Lee JH, Kim MJ, Ha SW, Kim HK. Autologous Platelet-rich Plasma Eye Drops in the Treatment of Recurrent Corneal Erosions. Korean J Ophthalmol. 2016 Apr;30(2):101-7. doi: 10.3341/kjo.2016.30.2.101. Epub 2016 Mar 25.
- Results publication: PubMed 29018685Wu TE, Chen CJ, Hu CC, Cheng CK. Easy-to-prepare autologous platelet-rich plasma in the treatment of refractory corneal ulcers. Taiwan J Ophthalmol. 2015 Jul-Sep;5(3):132-135. doi: 10.1016/j.tjo.2014.09.001. Epub 2014 Nov 20.
- Eye platelet-rich plasma in the treatment of ocular surface disordersLink provided by the sponsor.
- Platelet-Rich Plasma (PRP): What Is PRP and What Is Not PRP? Marx, Robert E. DDSLink provided by the sponsor.
- Treatment of Dry Eye Disease with Autologous Platelet-Rich PlasmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mohamed S Abdelrahman, MD study chair
Professor of ophthalmology, Faculty of medicine, Assiut University
Mahmoud F Rateb, MD study chair
Assistant professor of ophthalmology, Faculty of medicine, Assiut University
Mohamed G Saleh, MD study director
Lecturer of ophthalmology, Faculty of medicine, Assiut university
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous platelet rich plasma eye drops in people with Persistent Corneal Epithelial Defects and Dry Eye, run by Assiut University.
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 2 inclusion and 8 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Ahmed A Abdelnasser (01099427763 ext. +2, ahmedazzam200@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of platelet rich plasma eye drops in the management of persistent corneal epithelial defects, and dry eye disease by observation of change in size of defect over different periods of time. (time frame: At 48 hours, one week and one month.). The study lists 3 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 NCT05320172, which also lists 7 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 27 Feb 2023.