Pathogenetic Risk Factors for Corneal Graft Rejection

NCT06281587 | Completed

• 1 other identifier: SNFyodorov
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Graft Rejection

Keywords

penetrating keratoplasty; corneal graft rejection; corneal opacity; risk factors

Outcome Measures

Primary Outcomes (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.

  2011-2019

Study Arms (2)

Group 1 - low-risk (LR) keratoplasty

if the patient was diagnosed with keratoconus and there were no concomitant complicating diagnoses (n = 42)

Procedure: penetrating keratoplasty

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)

Procedure: penetrating keratoplasty

Interventions

penetrating keratoplasty PROCEDURE

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

Group 1 - low-risk (LR) keratoplasty; Group 2 - high-risk (HR) keratoplasty

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• completeness of data and records

Sponsors & Collaborators

• The S.N. Fyodorov Eye Microsurgery State Institution: lead

Study Sites (1)

Unknown Facility

Krasnodar, 350012, Russia

Location

Related Publications (9)

• 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.

  PMID: 10551286 RESULT

• 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.

  PMID: 28012874 RESULT

• 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.

  PMID: 21492957 RESULT

• 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.

  PMID: 27412098 RESULT

• 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.

  PMID: 15288984 RESULT

• 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.

  PMID: 25322173 RESULT

• 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.

  PMID: 31765363 RESULT

• 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.

  PMID: 30262982 RESULT

• 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.

  PMID: 29858043 RESULT

MeSH Terms

Conditions

Corneal Opacity

Interventions

Keratoplasty, Penetrating

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Transplantation; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2011
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)