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Graft RejectionNCT06281587

Pathogenetic Risk Factors for Corneal Graft Rejection

An observational study of Graft Rejection, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection. Read more about this study

Who is it for?
Ages 13 to 70 years
Conditions the study is for
Graft Rejection
What is being tested?
penetrating keratoplasty
Type of treatment
Surgery or procedure
How many people
93 participants
Where
1 siteRussia
Study dates
Jan 2011to Jan 2019
Phase
Observational
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 13 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: corneal inflammatory pathology (erosions, corneal ulcers, corneal fistulas,leucoma), complicated keratoconus, CGR or rekeratoplasty

Who may be able to join

  • completeness of data and records

Who cannot join

  • no

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Study site

    Krasnodar, 350012

Other trials in Russia

About this study

Official title: Pathogenetic Risk Factors for Corneal Graft Rejection in Penetrating Keratoplasty Patients

There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection.

Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity.

Read the detailed description

The pathogenesis of corneal graft rejection (CGR) is complex and is associated with numerous risk factors related to the donor, recipient and surgical technique.

Donor-related factors. These include AB0 and HLA incompatibility. Compared to corneal transplantation from a male donor to a male recipient, corneal transplantation from a male donor to a female recipient is associated with HR (high risk) CGR. Factors such as the method of storage of the donor cornea, sex mismatch between recipient and donor, and cause of death of the donor are not thought to have a significant impact on the outcome of keratoplasty. However, storage of donor tissue in organ culture medium for 7 days or more may reduce the incidence CGR.

Recipient-related factors. The most important risk factor for corneal graft rejection is the degree of corneal neovascularization (CNV) in the recipient. Another risk factor is rekeratoplasty. The presence of chronic diseases - herpes keratitis, uveitis, atopic dermatitis - also increases the risk of immune reactions. Dry eye syndrome (DES) and a history of glaucoma increase the risk of keratoplasty rejection. The presence of antibodies after rejection of other previously transplanted organs and blood transfusions can significantly increase the risk of rejection. Low limbal stem cell counts due to degradation of the limbal palisades of Vogt may lead to poor re-epithelialisation and development of corneal damage in the post-operative period.

Surgical factors. It has been observed that penetrating keratoplasty (PKP) has a lower graft survival rate than lamellar keratoplasty (LKP).

The aim of this study was to analyse the results of keratoplasty and to identify the risk factors for post-operative opacities of the corneal graft.

The study was conducted in accordance with the ethical standards of the authors' institutions and the Declaration of Helsinki (revised in 2013) and was approved by the Local Biomedical Ethics Committee of the The S.N. Fyodorov Eye Microsurgery State Institution no. 1 from 11.09.2019. Written informed consent was not required for participation in the study. The study was retrospective and patient data were anonymised.

Study design and groups The data of patients (n = 493) with corneal surgeries performed in " ISTC "Eye Microsurgery" named after Acad. S.N. Fedorov" Krasnodar for the period from 2011 to 2019. The results of keratoplasty were tracked at the patients' subsequent visits to the clinic until December 2021. Thus, the study included data from 8 years of postoperative follow-up of the patients.

In the next step, 93 medical records were selected from the entire cohort of patients who underwent penetrating keratoplasty (PKP), taking into account the completeness of data and records. These cases were divided into two groups without randomisation according to the primary diagnosis that indicated keratoplasty:

  • Group 1 - low-risk (LR) keratoplasty - if the patient was diagnosed with keratoconus and there were no concomitant complicating diagnoses (n = 42);
  • Group 2 - high-risk (HR) keratoplasty - in the presence of corneal dystrophy (pseudophakic bullous keratopathy, primary dystrophy), corneal inflammatory pathology (erosions, corneal ulcers, corneal fistulas,leucoma), complicated keratoconus, CGR or rekeratoplasty (n = 51).

Pharmacological management postoperative Antibiotics, antiseptics, keratoprotectors and Lubricating Eye Drops and gels were used for postoperative pharmacological management.

Methods of clinical evaluation of keratoplasty outcomes In the overall cohort group, recipient-related factors (ophthalmological and somatic status), primary and concomitant diagnoses, type of keratoplasty and postoperative complications were assessed.

In the next step, diagnostic data of the patients' ophthalmological examinations were obtained from electronic medical records and archives: examination and consultation by an ophthalmologist, refractometry, keratometry, visometry, tonometry, endothelial cell density (ECD), Schirmer test, optical coherence tomography (OCT) of the anterior segment, as well as graft characteristics and incidence of postoperative complications.

In groups 1 and 2, the assessment of graft transparency at each visit and signs of CGR, if present, were recorded in the medical records. CGR (or postoperative graft opacity) was defined if rekeratoplasty was performed and the loss of central graft transparency caused visual impairment for at least three consecutive months, if the patient's database or medical record mentioned the development of CGR as a diagnosis or postoperative complication. Stages of data analysis: 0 - at hospital admission before keratoplasty, 1, 3, 6, 9, 12 months after surgery. The anatomical results of keratoplasty (clear graft or postoperative graft opacity) in the cohort group and in groups 1 LR and 2 HR - were evaluated during the follow-up period of 8 years.

Conditions
Graft Rejection
Being tested
penetrating keratoplasty
Keywords
penetrating keratoplasty, corneal graft rejection, corneal opacity, risk factors
Medical subject headings
Corneal Opacity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • penetrating keratoplastyProcedure or surgery

    replacement of the affected tissue with healthy donor tissue in diseases that disrupt the shape or transparency of the cornea.

Study groups in NCT06281587
Study groupRoleWhat they receive
Group 1 - low-risk (LR) keratoplastyif the patient was diagnosed with keratoconus and there were no concomitant complicating diagnoses (n = 42)
Receives: Procedure: penetrating keratoplasty
Group 2 - high-risk (HR) keratoplastyin the presence of corneal dystrophy (pseudophakic bullous keratopathy, primary dystrophy), corneal inflammatory pathology (erosions, corneal ulcers, corneal fistulas,leucoma), complicated keratoconus, CGR or rekeratoplasty (n = 51)
Receives: Procedure: penetrating keratoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort group Kaplan-Meier survival analysis (clear graft engraftment)

    Investigators used Kaplan-Meier survival analysis to evaluate the survival (clear graft) of the corneal graft in this cohort.

    Measured: 2011-2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study startJan 2011
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06281587
Sponsor's protocol ID
SNFyodorov
Status last verified
Feb 2024
First submitted
31 Jan 2024
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not yet known if there will be a plan to make the iPad available.

Publications

  • Inoue K, Tsuru T. ABO antigen blood-group compatibility and allograft rejection in corneal transplantation. Acta Ophthalmol Scand. 1999 Oct;77(5):495-9. doi: 10.1034/j.1600-0420.1999.770501.x.

    PubMed 10551286
  • Di Zazzo A, Kheirkhah A, Abud TB, Goyal S, Dana R. Management of high-risk corneal transplantation. Surv Ophthalmol. 2017 Nov-Dec;62(6):816-827. doi: 10.1016/j.survophthal.2016.12.010. Epub 2016 Dec 22.

    PubMed 28012874
  • Guilbert E, Laroche L, Borderie V. [Rejection of corneal allografts]. J Fr Ophtalmol. 2011 May;34(5):331-48. doi: 10.1016/j.jfo.2011.02.001. Epub 2011 Apr 14. French.

    PubMed 21492957
  • Hopkinson CL, Romano V, Kaye RA, Steger B, Stewart RM, Tsagkataki M, Jones MN, Larkin DF, Kaye SB; National Health Service Blood Transplant Ocular Tissue Advisory Group and Contributing Ophthalmologists (OTAG Study 20). The Influence of Donor and Recipient Gender Incompatibility on Corneal Transplant Rejection and Failure. Am J Transplant. 2017 Jan;17(1):210-217. doi: 10.1111/ajt.13926. Epub 2016 Jul 22.

    PubMed 27412098
  • Simon M, Fellner P, El-Shabrawi Y, Ardjomand N. Influence of donor storage time on corneal allograft survival. Ophthalmology. 2004 Aug;111(8):1534-8. doi: 10.1016/j.ophtha.2003.12.060.

    PubMed 15288984
  • Writing Committee for the Cornea Donor Study Research Group; Sugar A, Gal RL, Kollman C, Raghinaru D, Dontchev M, Croasdale CR, Feder RS, Holland EJ, Lass JH, Macy JI, Mannis MJ, Smith PW, Soukiasian SH, Beck RW. Factors associated with corneal graft survival in the cornea donor study. JAMA Ophthalmol. 2015 Mar;133(3):246-54. doi: 10.1001/jamaophthalmol.2014.3923.

    PubMed 25322173
  • Armitage WJ, Goodchild C, Griffin MD, Gunn DJ, Hjortdal J, Lohan P, Murphy CC, Pleyer U, Ritter T, Tole DM, Vabres B. High-risk Corneal Transplantation: Recent Developments and Future Possibilities. Transplantation. 2019 Dec;103(12):2468-2478. doi: 10.1097/TP.0000000000002938.

    PubMed 31765363
  • Yamaguchi T, Higa K, Tsubota K, Shimazaki J. Elevation of preoperative recipient aqueous cytokine levels in eyes with primary graft failure after corneal transplantation. Mol Vis. 2018 Sep 13;24:613-620. eCollection 2018.

    PubMed 30262982
  • Siebelmann S, Ramos SL, Matthaei M, Scholz P, Schrittenlocher S, Heindl LM, Bachmann B, Cursiefen C. Factors Associated With Early Graft Detachment in Primary Descemet Membrane Endothelial Keratoplasty. Am J Ophthalmol. 2018 Aug;192:249-250. doi: 10.1016/j.ajo.2018.05.010. Epub 2018 May 29. No abstract available.

    PubMed 29858043

Questions about this trial

What is this clinical trial studying?

An observational study of Graft Rejection, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort group Kaplan-Meier survival analysis (clear graft engraftment) (time frame: 2011-2019). 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 NCT06281587, which also lists 9 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 28 Feb 2024.

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