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PRGF group for Corneal Edema

N/A
Waitlist Available
Led By Alfonso Sabater, MD
Research Sponsored by Price Vision Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3 and 12 months
Awards & highlights

Study Summary

This trial aims to see if soaking corneal tissue in a special growth factor solution before surgery can help reduce damage to cells on the cornea. Patients having corneal surgery will be randomly assigned

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a surgical procedure, potential side effects may include typical risks associated with eye surgeries such as infection, inflammation, or reaction to PRGF; however, specific side effects of PRGF are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a specific cornea transplant within 2 weeks of tissue preservation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial cell loss at 6 months
Secondary outcome measures
Best corrected visual acuity
Corneal endothelial cell density
Endothelial cell loss
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Control groupActive Control1 Intervention
Standard endothelial keratoplasty procedure
Group II: PRGF groupActive Control1 Intervention
Immediately prior to endothelial keratoplasty, the graft will be incubated for 15 minutes in plasma rich in growth factors obtained from the transplant recipient.

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Who is running the clinical trial?

Price Vision GroupLead Sponsor
11 Previous Clinical Trials
1,583 Total Patients Enrolled
3 Trials studying Corneal Edema
140 Patients Enrolled for Corneal Edema
Alfonso Sabater, MDPrincipal InvestigatorBascom Palmer Eye Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"The ongoing clinical trial, as documented on clinicaltrials.gov, is presently not actively enrolling participants. The initial posting date of this study was 20th February 2024 with the most recent update recorded on 7th February 2024. While this particular trial does not seek volunteers currently, it's noteworthy that there are sixteen alternative trials actively seeking eligible candidates at present."

Answered by AI

Which group of individuals would be considered the most suitable candidates for participation in this clinical research study?

"Candidates aged between 18 and 80 with corneal edema are eligible to participate in this trial, which aims to enroll approximately 100 individuals."

Answered by AI

Is the clinical trial accepting participants who are older than 60 years?

"Participants sought for this investigation must be over 18 years old but under the age of 80."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
2024. "Plasma Rich in Growth Factors in Corneal Endothelial Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261346.
~67 spots leftby Apr 2026
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