Use of autologous blood products to enhance the survival of corneal transplants
| ISRCTN | ISRCTN12328428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12328428 |
| Secondary identifying numbers | 27921992 |
- Submission date
- 27/07/2023
- Registration date
- 28/07/2023
- Last edited
- 17/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
In a corneal transplant all or part of a damaged cornea (the clear outer layer at the front of the eye) is removed and replaced with healthy cornea tissue from the eye of a dead donor. During corneal transplantation its normal for some corneal cells to be lost, which can lead to problems like the transplanted tissue not working properly or being rejected by the body. Inflammation and manipulation of the tissue are significant factors in causing the loss of these cells after surgery. In previous studies, using a substance called plasma rich in growth factors (PRGF), which is a product extracted from the patients’ blood, can help protect the cells from this stress and prevent them from dying. The aim of this study is to see if soaking the corneal cells in PRGF for 15 minutes during surgery can reduce the number of cells lost after the procedure. The researchers will be assessing both how well it works and if it's safe to do.
Who can participate?
Patients over 18 years old undergoing corneal transplantation at Clinica Barraquer de America
What does the study involve?
Participants will be randomly allocated to receive corneal transplants incubated with either activated platelet-rich plasma (aPRP) or PRGF.
What are the possible benefits and risks of participating?
Benefits: Lower endothelial cell loss compared to usual corneal transplant procedures and longer transplant survival.
Risks: Same as any usual corneal transplant
Where is the study run from?
Instituto Barraquer de América (Colombia)
When is the study starting and how long is it expected to run for?
June 2019 to March 2023
Who is funding the study?
Francisco Barraquer-Coll Research Grant, Instituto Barraquer de América (Colombia)
Who is the main contact?
Carolina Mercado, cxm2533@med.miami.edu
Contact information
Principal Investigator
900 nw 17th st
Miami
33136
United States of America
 ORCID ID |
0000-0002-1608-3563 |
|---|---|
| Phone | +57 (0)7868900892 |
| cxm2533@med.miami.edu |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Safety and efficacy of brief intraoperative incubation of full-thickness corneal grafts in autologous plasma products for reducing postoperative endothelial cell loss |
| Study objectives | Autologous plasma products (aPRP and PRGF) throughout its antioxidant role may prevent the cytotoxic effects induced by oxidative stress, thus reducing corneal endothelial cell loss after penetrating keratoplasty. |
| Ethics approval(s) |
Approved 04/06/2021, CEI-ESOIBA (Ac 100 #18a-51, Bogota, -, Colombia; +57 (0)6012187077; mojimenezp.esoiba@barraquer.edu.co), ref: N/A |
| Health condition(s) or problem(s) studied | Prevention of corneal endothelial cell loss after penetrating keratoplasty |
| Intervention | Prospective randomized trial of patients undergoing penetrating keratoplasty by three surgeons. Participants who agreed to undergo intervention were randomly assigned by block randomisation to either of the treatment groups (aPRP incubation for 15 minutes intraoperatively or PRGF incubation for 15 minutes intraoperatively). Patients who declined intervention were followed as controls. The effect of aPRP on postoperative endothelial cell loss following corneal transplantation was evaluated by specular microscopy. The researchers also assessed pachymetry and intraocular pressure on follow-up. |
| Intervention type | Supplement |
| Primary outcome measure | Postoperative endothelial cell loss using endothelial cell counts on specular microscopy at 1st, 3rd, and 6th postoperative months |
| Secondary outcome measures | 1. Hexagonality measured using specular microscopy at 1st, 3rd, and 6th postoperative months 2. Corneal thickness using specular microscopy at 1st, 3rd, and 6th postoperative months |
| Overall study start date | 04/06/2019 |
| Completion date | 07/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Patients older than 18 years 2. Undergoing penetrating keratoplasty for any reason by the previously mentioned surgeons from June 2021 to December 2022 3. All the tissue was provided by the same Eye Bank (COBANCOL), with no more than 14 days of preservation |
| Key exclusion criteria | 1. Tissue from another institution operated by other surgeons 2. Patients from vulnerable populations. 3. Patients with renal failure, anemia, or immunosuppressed 4. Patients with previous trabeculectomies or glaucoma valve implants |
| Date of first enrolment | 28/06/2021 |
| Date of final enrolment | 02/02/2023 |
Locations
Countries of recruitment
- Colombia
Study participating centre
BOGOTA
-
Colombia
Sponsor information
Research organisation
Ac 100 #18a-51
Bogotá
-
Colombia
| Phone | +57 (0)2187077 |
|---|---|
| mojimenezp.esoiba@barraquer.edu.co | |
| Website | https://www.institutobarraquer.com/ |
"ROR" |
https://ror.org/02q3wgj37 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers have presented preliminary results of this study in: Eighth Fuchs Symposium, 59th annual Bascom Palmer Residents Day, EBAA Cornea and Eye Banking Forum 2022, ASCRS 2022. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Carolina Mercado MD (caromercadoa@gmail.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/08/2024 | 17/04/2025 | Yes | No |
Editorial Notes
17/04/2025: Publication reference added.
26/03/2024: The study contact email was amended.
28/07/2023: Study's existence confirmed by the ethics comittee from Clinica Barraquer.
