Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Keratoconus
- Sponsor
- Istituto Internazionale di Ricerca e Formazione in Oftalmologia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in best spectacle-corrected visual acuity
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Keratoconus
- •Surgical candidates for deep anterior lamellar keratoplasty
Exclusion Criteria
- •Ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease)
- •Previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery
- •Inability to comply with study protocol or participate in follow-up visits
Outcomes
Primary Outcomes
Change in best spectacle-corrected visual acuity
Time Frame: Preoperatively; and 6 and 12 months postoperatively
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
Secondary Outcomes
- Change in astigmatism(Preoperatively; and 6 and 12 months postoperatively)
- Change in Thinnest-point pachymetry(Preoperatively; and 6 and 12 months postoperatively)
- Change in endothelial cell density(Preoperatively; and 6 and 12 months postoperatively)
- Incidence of graft rejection(6 and 12 months postoperatively)
- Incidence of graft failure(6 and 12 months postoperatively)
- Corneal donor loss due to preparation(Intraoperative)