Keratoconus
Conditions
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.
Interventions
PROCEDUREDeep anterior lamellar keratoplasty
Deep anterior lamellar keratoplasty using dehydrated corneas
Sponsors
Istituto Internazionale di Ricerca e Formazione in Oftalmologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in best spectacle-corrected visual acuity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in astigmatism | Preoperatively; and 6 and 12 months postoperatively | Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA) |
| Change in Thinnest-point pachymetry | Preoperatively; and 6 and 12 months postoperatively | Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA) |
| Change in endothelial cell density | Preoperatively; and 6 and 12 months postoperatively | Measured using noncontact specular microscopy |
| Incidence of graft failure | 6 and 12 months postoperatively | Clinically assessed during postoperative examinations |
| Corneal donor loss due to preparation | Intraoperative | Based on intraoperative assessment of corneas unusable for corneal transplantation |
| Incidence of graft rejection | 6 and 12 months postoperatively | Clinically assessed during postoperative examinations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Refraction | 6 and 12 months postoperatively | Measured by manifest refraction |
| Adverse Events/Complication | up to 12 months postoperatively | Comparison of total rates of adverse events/complications assessed clinically |
Countries
Italy
Contacts
Primary ContactMassimo Busin, MD
Backup ContactAngeli Christy Yu, MD
Outcome results
None listed