PURPOSE: To compare 2 lenticule insertion methods currently in use for Descemet stripping automated endothelial keratoplasty (DSAEK). DESIGN: Prospective randomized single-masked study. PATIENTS AND METHODS: Twenty patients with Fuchs endothelial dystrophy and pseudophakic bullous keratopathy undergoing DSAEK surgery were included and randomized to the use of either EndoGlide or EndoSerter as a delivery method for the donor lenticule. Post surgery, patients were monitored for up to 1 year. Evaluation included corrected distance visual acuity (CDVA) and refraction. Specular microscopy images were obtained at the 6- and 12-month visits. Complications, including rebubbling rate, graft dislocation, and graft failure, were recorded. RESULTS:Twenty eyes were randomized to receive the Tan EndoGlide or the EndoSerter injector for lenticule insertion. Mean patient age was 65.9±8.4 years and 70.3±9.8 years in the Tan EndoGlide and EndoSerter groups, respectively (P=.3). Two eyes in each group needed rebubbling. The mean endothelial cell loss, including the rebubbled eyes, at the 12-month visit was 1093±629 cells/mm2 (range: 239-2109 cells/mm2, mean percentage cell loss 41.2%) and 877±566 cells/mm2 (range: 116-1851 cells/mm2, mean percentage cell loss 31.4%) in the Tan EndoGlide and EndoSerter groups, respectively (P=.45). Mean CDVA did not show a statistically significant difference between the 2 groups at the 6- or 12-month visit. CONCLUSION: The EndoSerter shows comparable results to the Tan EndoGlide. However, further investigation is warranted in order to validate these findings.
RCT Entities:
PURPOSE: To compare 2 lenticule insertion methods currently in use for Descemet stripping automated endothelial keratoplasty (DSAEK). DESIGN: Prospective randomized single-masked study. PATIENTS AND METHODS: Twenty patients with Fuchs endothelial dystrophy and pseudophakic bullous keratopathy undergoing DSAEK surgery were included and randomized to the use of either EndoGlide or EndoSerter as a delivery method for the donor lenticule. Post surgery, patients were monitored for up to 1 year. Evaluation included corrected distance visual acuity (CDVA) and refraction. Specular microscopy images were obtained at the 6- and 12-month visits. Complications, including rebubbling rate, graft dislocation, and graft failure, were recorded. RESULTS: Twenty eyes were randomized to receive the Tan EndoGlide or the EndoSerter injector for lenticule insertion. Mean patient age was 65.9±8.4 years and 70.3±9.8 years in the Tan EndoGlide and EndoSerter groups, respectively (P=.3). Two eyes in each group needed rebubbling. The mean endothelial cell loss, including the rebubbled eyes, at the 12-month visit was 1093±629 cells/mm2 (range: 239-2109 cells/mm2, mean percentage cell loss 41.2%) and 877±566 cells/mm2 (range: 116-1851 cells/mm2, mean percentage cell loss 31.4%) in the Tan EndoGlide and EndoSerter groups, respectively (P=.45). Mean CDVA did not show a statistically significant difference between the 2 groups at the 6- or 12-month visit. CONCLUSION: The EndoSerter shows comparable results to the Tan EndoGlide. However, further investigation is warranted in order to validate these findings.
Authors: Jonathan H Lass; Loretta B Szczotka-Flynn; Allison R Ayala; Beth A Benetz; Robin L Gal; Anthony J Aldave; Michelle M Corrigan; Steven P Dunn; Ty L McCall; Sudeep Pramanik; George O Rosenwasser; Kevin W Ross; Mark A Terry; David D Verdier Journal: Cornea Date: 2015-06 Impact factor: 2.651