The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation. Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored. The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Deep anterior lamellar keratoplasty using dehydrated corneas
Deep anterior lamellar keratoplasty using standard organ culture stored corneas
Ospedali Privati Forlì "Villa Igea"
Forlì, Emilia-Romagna, Italy
RECRUITINGChange in best spectacle-corrected visual acuity
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
Time frame: Preoperatively; and 6 and 12 months postoperatively
Change in astigmatism
Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)
Time frame: Preoperatively; and 6 and 12 months postoperatively
Change in Thinnest-point pachymetry
Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)
Time frame: Preoperatively; and 6 and 12 months postoperatively
Change in endothelial cell density
Measured using noncontact specular microscopy
Time frame: Preoperatively; and 6 and 12 months postoperatively
Incidence of graft rejection
Clinically assessed during postoperative examinations
Time frame: 6 and 12 months postoperatively
Incidence of graft failure
Clinically assessed during postoperative examinations
Time frame: 6 and 12 months postoperatively
Corneal donor loss due to preparation
Based on intraoperative assessment of corneas unusable for corneal transplantation
Time frame: Intraoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.