[Immunological graft reactions after penetrating keratoplasty - A prospective randomized trial comparing corneal excimer laser and motor trephination].

BACKGROUND AND PURPOSE

Nonmechanical trephination has been established as an advantageous procedure in penetrating keratoplasty (PK) for avascular corneal diseases and has been performed successfully in more than 1000 eyes at our institution. The purpose of this study was to compare incidence, type and reversibility of immunological graft reactions after mechanical and nonmechanical trephination for PK.

PATIENTS AND METHODS

As part of a prospective randomized clinical trial 179 eyes of 76 females and 103 males were included, that had primary central PK without previous intraocular surgery between 10/1992 and 12/1997 for Fuchs' dystrophy (diameter 7.5 mm, n=73) or keratoconus (8.0 mm, n=106). The recipient and donor trephinations were performed from the epithelial side using either a motor trephine (Microkeratron, Geuder, n=91) or an 193-nm excimer laser (MEL60, Aesculap-Meditec, 1.5 x 1.5 mm spot mode, 16 - 24 mJ/pulse, repetition rate 25/s) along round metal masks with 8 "orientation teeth/notches" (n=88). As a routine, donor oversize was 0.1 mm. 128 patients (72 %) had PK only, 51 patients had simultaneous cataract extraction and PC-IOL implantation (triple procedure). Wound closure was achieved using a 16-bite double running diagonal suture by one surgeon (G.O.H.N.). In 53 % of procedures short-term-preserved donor tissue, in 47 % organ-cultured tissue was used. The mean patient/donor age was 51 +/- 17/57 +/- 19 years with nonmechanical trephination and 50 +/- 19/58 +/- 20 years with mechanical trephination. Incidence, type and reversibility of endothelial immunologic graft reactions were recorded continuously by clinical follow-up in an outpatient service with cornea specialization (after 6 weeks, then every 3 months until after suture removal, then every half year).

RESULTS

During a mean follow-up of 40 +/- 15 months, 7.3 % of eyes developed an immunological endothelial graft reaction. Acute diffuse (5.6 %) were more frequent than chronic focal reactions (1.7 %). Only 1.7 % of grafts became irreversibly cloudy. More than 80 % of all graft reactions occurred later than one year (on average 23 +/- 13 months) after PK. Neither incidence (p=0.82, Chi square test) nor cumulative 3-year-rate of immunological graft reactions (p=0.91, LogRank test) differed significantly comparing nonmechanical (6.8 % or 7.3 %) and mechanical (7.7 % or 5.6 %) trephination. In eyes with keratoconus (6.6 %, 16 +/- 8 months) graft reactions did not occur more frequently (p=0.68) but earlier (p=0.02) than in eyes with Fuchs' dystrophy (8.2 %, 31 +/- 11 months). Donor age, post-mortem-time and preservation period did not significantly affect the rate of graft reactions in our study setting.

CONCLUSIONS

Besides well-established optical advantages, nonmechanical trephination using the excimer laser seems to have no immunologic drawbacks in contrast to conventional mechanical trephination. Donor parameters appear to have no major impact on the incidence of graft reactions after non-high-risk PK. Rather, an adequate postoperative therapy with topical steroids, an informed patients' compliance, a consequent long-term follow-up in a clinical out-patient service with corneal specialization and a good education of and cooperation with the referring ophthalmologists are of utmost importance for the clear corneal graft in the long run.