ERLANGEN NON-HIGH-RISK-KERATOPLASTY STUDY: STUDY PROTOCOL AND FIRST RESULT
N.X. Nguyen1, A. Langenbucher1, M.M. Kus1, M. Küchle1, P. Martus2, G.O.K. Naumann1
Immunologic graft rejection is the most frequent cause of graft failure after corneal transplantation. The purpose of this prospective study is to examine clinical and immunological risk factors for graft rejection after non-high-risk-keratoplasty (PK)
Patients and Methods: From l/97 to l/98, one hundred patients have been enrolled in this study. Exclusion criteria are vascularized corneal scars, mucocutaneous syndrome, immunosuppressive conditions and re-keratoplasty. Preoperatively and postoperatively complete ophthalmological examination included specular microscopy, corneal pachymetry and quantification of the blood-aqueous barrier (BAB) using laser flare-cell meter. Preoperatively as well as at each postoperative examination, recipient serum and perioperatively corneoscleral donor tissue were collected and frozen to allow later immunological and serological examinations. The postoperative treatment was standardized and randomized into 2 groups: group l stopping the local steroidal treatment after 6 months and group 2 continuing local steroidal treatment up to one year. Clinical and immunological parameters were recorded in a relational data base (MS Access).
Results: During follow-up (8.5 ± 3.5 months), no corneal graft rejection was seen so far. The mean visual acuity increased from 0.15 ±0.15 to 0.5 ± 0.2. Corneal topography regularized over time. The BAB normalized 6 weeks after PK. Postoperatively the mean endothelial cell density was 2078 ± 547/mm2 and mean corneal thickness was 543 ± 53 µm.
Conclusion: The Erlangen Study is expected to allow standardized evaluation of immunological graft rejection and a retrospective correlation between clinical and immunological risk factors after non-high-risk-keratoplasty.
Supported by BMFT, IZKF, Project B13
1Department of Ophthalmology,
2Institute of Medical Statistic and Documentation of the University of Erlangen-Nürnberg, Schwabachanlage 6, D-91054 Erlangen, Germany