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

Trial Summary

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 data supports the effectiveness of the treatment Plasma Rich in Growth Factors (PRGF) for corneal surgery?

Research shows that Plasma Rich in Growth Factors (PRGF) can help heal persistent corneal defects and other eye surface disorders by promoting cell growth and repair. Studies in animals and humans suggest that PRGF can improve healing after eye surgeries and reduce complications from other eye treatments. ^{1 2 3 4 5}

Is PRGF safe for use in humans?

Research shows that plasma rich in growth factors (PRGF) eyedrops have been used safely in treating various eye conditions, including dry eye and other ocular surface disorders. These studies suggest that PRGF is generally safe for human use. ^{1 5 6 7 8}

How is the treatment Plasma Rich in Growth Factors (PRGF) unique for corneal surgery?

Plasma Rich in Growth Factors (PRGF) is unique because it uses a patient's own blood to create a plasma that is rich in proteins promoting healing and tissue repair, which is applied directly to the eye. This personalized approach can enhance the healing process of the cornea, unlike standard treatments that may not use the body's own regenerative components. ^{1 2 9 10 11}

What is the purpose of this trial?

The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.

Research Team

Alfonso L Sabater, MD

Principal Investigator

Bascom Palmer Eye Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors as a therapeutic agent for persistent corneal epithelial defects. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors for the Treatment of Ocular Surface Diseases. [2022]

3. England 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. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Effect of Plasma Rich in Growth Factors-Endoret in Stromal Wound Healing in Additive Surgery. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors eye drops to treat secondary ocular surface disorders in patients with glaucoma. [2022]

6. United States 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. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Autologous Plasma Rich in Growth Factors Eye Drops for the Treatment of Evaporative Dry Eye. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Autologous Plasma Rich in Growth Factors Eyedrops in Refractory Cases of Ocular Surface Disorders. [2022]

9. United States 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Progress in the use of plasma rich in growth factors in ophthalmology: from ocular surface to ocular fundus. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Plasma Rich in Growth Factors for the Treatment of Dry Eye after LASIK Surgery. [2018]