PRGF for Corneal Surgery

Recruiting at 1 trial location

Overseen By Alfonso L Sabater, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Corneal transplant, Immunosuppression, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether plasma rich in growth factors (PRGF) can protect eye cells during corneal surgery. Researchers aim to determine if this treatment safely reduces cell loss in the cornea (the clear front part of the eye) after surgery. Participants are divided into two groups: one receives standard surgery, while the other has their corneal tissue treated with PRGF before surgery. Ideal participants are those undergoing specific corneal surgeries (DSEK or DMEK) at certain medical centers, using corneal graft tissue less than 14 days old. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for corneal surgery?

Research has shown that Plasma Rich in Growth Factors (PRGF) is generally safe for eye treatments. Early results indicate that PRGF aids in the healing and regeneration of eye tissue. Other studies have safely used PRGF to treat post-surgical eye issues, such as keratoneuralgia, a painful nerve condition. These studies found no major safety concerns or side effects. Overall, evidence suggests that PRGF is well-tolerated and safe for use in eye surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Plasma Rich in Growth Factors (PRGF) for corneal surgery because it represents a novel approach to enhancing healing. Unlike traditional treatments for corneal conditions, such as standard endothelial keratoplasty which primarily focuses on replacing damaged corneal tissue, PRGF is thought to enhance the body's natural healing processes by using growth factors derived from the patient's own blood plasma. This could potentially lead to faster recovery times and improved outcomes by promoting better tissue regeneration. The use of the patient's own plasma also minimizes the risk of adverse reactions, making this approach a promising advancement in corneal surgery.

What evidence suggests that plasma rich in growth factors is effective for reducing postoperative endothelial cell loss?

Research has shown that Plasma Rich in Growth Factors (PRGF), which participants in this trial may receive, can aid recovery after eye surgery. One study found that PRGF significantly increased tear production and enhanced sensitivity to touch in many patients. Another study demonstrated that PRGF was safe for the inner layer of the cornea during surgery. Additionally, PRGF improved vision clarity for patients. These findings suggest that PRGF could reduce cell loss and support recovery after corneal surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Alfonso L Sabater, MD

Principal Investigator

Bascom Palmer Eye Institute

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for corneal endothelial transplantation due to conditions like Corneal Edema or Fuchs' Dystrophy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could impact the study's results.

Inclusion Criteria

I am having a specific cornea transplant within 2 weeks of tissue preservation.

Exclusion Criteria

Best-corrected visual acuity (BCVA) worse than 20/40 in the contralateral eye

I have had a corneal transplant in one of my eyes.

I am on medication that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endothelial keratoplasty procedure with or without PRGF incubation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits over 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Plasma Rich in Growth Factors

Trial Overview The trial is testing if soaking the corneal graft in a solution called Plasma Rich in Growth Factors (PRGF) before implantation can reduce cell loss in the cornea six months after surgery compared to not using PRGF.

How Is the Trial Designed?

Group I: PRGF group Experimental Treatment 2 Interventions

Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.

Group II: Control group Active Control 1 Intervention

Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Price Vision Group

Lead Sponsor

Trials

12

Recruited

1,700+

Florida lions eye bank

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Plasma rich in growth factors (PRGF) is being increasingly used in ophthalmology for treating both acute and chronic eye conditions, showing promising results in diseases like Sjögren syndrome and cicatrizing conjunctivitis.

Recent advancements allow PRGF to be stored for up to 12 months and used in various formulations, including eye drops and fibrin-based products, enhancing its therapeutic potential in ocular surgeries and treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in the use of plasma rich in growth factors in ophthalmology: from ocular surface to ocular fundus. Anitua, E., de la Sen-Corcuera, B., Orive, G., et al.[2022]

The study found that immersing intrastromal corneal ring segments (ICRS) in plasma rich in growth factors (PRGF) before and after implantation led to enhanced clinical outcomes, such as faster epithelial wound closure and reduced corneal edema in an animal model of 18 hens.

Histologically, the PRGF-ICRS group showed increased cell turnover and proliferation without increasing myofibroblast differentiation, suggesting that PRGF may improve healing after ICRS surgery without causing excessive scarring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Effect of Plasma Rich in Growth Factors-Endoret in Stromal Wound Healing in Additive Surgery. Ibares-Frías, L., Gallego-Muñoz, P., Orive, G., et al.[2021]

In a study of 77 eyes from 42 patients, PRGF eye drops significantly improved dry eye symptoms after LASIK surgery, showing a 38.12% improvement in the Ocular Surface Disease Index and notable enhancements in other measures like visual analogue scale scores and Schirmer test results.

No adverse events were reported with PRGF treatment, indicating it is a safe and effective alternative to conventional therapies for managing postoperative dry eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors for the Treatment of Dry Eye after LASIK Surgery. Sanchez-Avila, RM., Merayo-Lloves, J., Fernandez, ML., et al.[2018]

PRGF-Endoret technology, which uses autologous platelet-enriched plasma, significantly enhances the proliferation and migration of keratocytes and conjunctival fibroblasts, promoting wound healing in the ocular surface.

This technology also effectively prevents and inhibits the differentiation of fibroblasts into myofibroblasts, which could help reduce scarring during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors (PRGF-Endoret) stimulates proliferation and migration of primary keratocytes and conjunctival fibroblasts and inhibits and reverts TGF-beta1-Induced myodifferentiation. Anitua, E., Sanchez, M., Merayo-Lloves, J., et al.[2022]

In a study of six glaucoma patients with secondary ocular surface disorders, treatment with plasma rich in growth factors (PRGF) eye drops led to significant improvements in ocular surface symptoms, with a 50.6% reduction in the Ocular Surface Disease Index (OSDI) and a 41.8% improvement in best-corrected visual acuity (BCVA).

The treatment also resulted in a 16.6% decrease in intraocular pressure (IOP), and was generally well-tolerated, with only one patient reporting mild itching as an adverse event, suggesting that PRGF eye drops could be a safe and effective option for managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors eye drops to treat secondary ocular surface disorders in patients with glaucoma. Sánchez-Avila, RM., Merayo-Lloves, J., Fernández, ML., et al.[2022]

Plasma rich in growth factors (PRGF) utilizes the patient's own proteins and growth factors to promote healing in ocular surface disorders, showing promise in regenerative medicine.

Preliminary results indicate that PRGF is both safe and effective for enhancing ocular tissue regeneration, paving the way for personalized treatment options in ophthalmology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors for the Treatment of Ocular Surface Diseases. Anitua, E., Muruzabal, F., de la Fuente, M., et al.[2022]

Topically applied autologous plasma rich in growth factors (PRGF) successfully healed epithelial defects in 85% of cases (17 out of 20 eyes) with a mean healing time of approximately 10.9 weeks, indicating its efficacy for treating persistent epithelial defects (PEDs) of the cornea.

The study involved 20 eyes from 18 patients with various underlying causes of PED, and the PRGF treatment was characterized by high concentrations of key growth factors, suggesting a strong mechanism of action in promoting corneal healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors as a therapeutic agent for persistent corneal epithelial defects. López-Plandolit, S., Morales, MC., Freire, V., et al.[2022]

In a study of 153 patients using plasma rich in growth factors (PRGF) eyedrops for ocular surface diseases, 74.3% showed improvement in corneal staining after 3 months, indicating significant efficacy in treating conditions like dry eye and neurotrophic keratopathy.

The treatment was found to be safe, with only 0.98% of patients reporting mild side effects, and symptoms significantly decreased from a median SANDE score of 90 to 34.6 after 6 months of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter report of the use of plasma rich in growth factors (PRGF) for the treatment of patients with ocular surface diseases in North America. Soifer, M., Tovar, A., Wang, M., et al.[2022]

In a study of 83 patients with evaporative dry eye, treatment with plasma rich in growth factors (PRGF) led to significant improvements in symptoms and signs of the condition, including a 38.2% reduction in the Ocular Surface Disease Index and a 177.5% improvement in Schirmer test scores.

The treatment was found to be safe, with only four mild adverse events reported, all of which resolved quickly, indicating that PRGF eye drops could be a promising option for managing evaporative dry eye.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Autologous Plasma Rich in Growth Factors Eye Drops for the Treatment of Evaporative Dry Eye. Merayo-Lloves, J., Sanchez-Avila, RM., Riestra, AC., et al.[2022]

In a study of 41 patients with refractory ocular surface disorders, treatment with plasma rich in growth factors (PRGF) eyedrops led to significant improvements in symptoms and visual acuity, with reductions in the ocular surface disease index by 39.27% and an improvement in best-corrected visual acuity by 54.86%.

The treatment was found to be safe, with only two mild adverse events reported (eye redness and eyelid inflammation) that resolved quickly, suggesting PRGF eyedrops could be a viable option for patients who do not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Plasma Rich in Growth Factors Eyedrops in Refractory Cases of Ocular Surface Disorders. Merayo-Lloves, J., Sanchez, RM., Riestra, AC., et al.[2022]

Autologous serum derived from plasma rich in growth factors (s-PRGF) significantly enhances corneal wound healing in rabbits, showing similar effectiveness to fetal bovine serum (FBS) in promoting cell proliferation and re-epithelialization.

In vivo studies revealed that 100% s-PRGF treatment notably accelerated corneal healing compared to control treatments, with histological analysis confirming normal epithelialization and increased keratocyte density, indicating a potential chemotactic effect of s-PRGF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum from plasma rich in growth factors regenerates rabbit corneas by promoting cell proliferation, migration, differentiation, adhesion and limbal stemness. Etxebarria, J., Sanz-Lázaro, S., Hernáez-Moya, R., et al.[2018]

Citations

1. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1368117/full

Safety of intraoperative autologous plasma incubation ... In conclusion, our study found that aPRP and PRGF-Endoret were safe for the corneal endothelium. Based on the postoperative clinical findings, ...

2. trialx.com trialx.com/clinical-trials/listings/295711/plasma-rich-in-growth-factors-in-corneal-endothelial-transplantation/

Plasma Rich in Growth Factors in Corneal Endothelial ... The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10350222/

Efficacy of Plasma Rich in Growth Factors (PRGF) in Stage ... The results from the present study show that tear film production and corneal sensitivity improved significantly (P-value < 0.01) in 80.7% (21/26) and 53.8% (14 ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2018/04270/plasma_rich_in_growth_factors_membrane_as.3.aspx

Plasma rich in growth factors membrane as coadjuvant... Results showed an improvement in BCVA in all patients, with an overall improvement of 2.9 in Vision Lines. The BCVA significantly improved (P < .05) in the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9448984/

Initial experiences using plasma rich in growth factors to treat ... PRGF is safe and can potentially alleviate symptoms in patients with keratoneuralgia, a rare but devastating complication after refractive surgery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11345243/

Safety of intraoperative autologous plasma incubation ... This study aimed to evaluate the safety of intraoperative incubation of full-thickness corneal grafts in platelet-rich plasma (aPRP) and plasma ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39188872

Safety of intraoperative autologous plasma incubation ... This study aimed to evaluate the safety of intraoperative incubation of full-thickness corneal grafts in platelet-rich plasma (aPRP) and plasma ...

8. withpower.com withpower.com/trial/phase-corneal-edema-1-2024-3ff95

PRGF for Corneal Surgery Preliminary results indicate that PRGF is both safe and effective for enhancing ocular tissue regeneration, paving the way for personalized treatment options in ...

9. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.946828/full

Initial experiences using plasma rich in growth factors to ... PRGF is safe and can potentially alleviate symptoms in patients with keratoneuralgia, a rare but devastating complication after refractive surgery.