An interventional study of Deep anterior lamellar keratoplasty and Deep anterior lamellar keratoplasty in Keratoconus, sponsored by Istituto Internazionale di Ricerca e Formazione in Oftalmologia. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Istituto Internazionale di Ricerca e Formazione in Oftalmologia · Not applicable, Interventional, and Treatment
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →This is the only study on the registry with Istituto Internazionale di Ricerca e Formazione in Oftalmologia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Corneal transplantation of anterior lamellar grafts from dehydrated corneas.
Procedure: Deep anterior lamellar keratoplasty
Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.
Procedure: Deep anterior lamellar keratoplasty
Deep anterior lamellar keratoplasty using dehydrated corneas
Deep anterior lamellar keratoplasty using standard organ culture stored corneas
Change 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
Refraction
Measured by manifest refraction
Time frame: 6 and 12 months postoperatively
Adverse Events/Complication
Comparison of total rates of adverse events/complications assessed clinically
Time frame: up to 12 months postoperatively
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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