Keratoplasty (corneal transplantation). Corneal transplant status
Conditions
Interventions
Intervention 1: Intervention group: Participants in the intervention group (ZiSol group) will be patients eligible for corneal transplantation who will undergo keratoplasty using donor tissue preserve
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Bullous keratopathy for DSAEK Fuchs endothelial corneal dystrophy (FECD) for DSAEK Keratoconus (KCN) for PKP Pellucid marginal degeneration (PMD) for PKP Healed keratitis for PKP Corneal stromal dystrophies for PKP
Exclusion criteria
Exclusion criteria: history of prior corneal transplantation age under 18 years preexisting glaucoma clinical signs of anterior or posterior segment inflammation ocular surface disease posterior segment pathology unwillingness to participate or adhere to follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety. Timepoint: safety will be assessed at 1 week, 1, 3, and 6 months following keratoplasty. Method of measurement: Epithelial toxicity, conjunctival hyperemia and allergic reactions to the storage medium will be assessed by slit lamp biomicroscope. | — |
Secondary
| Measure | Time frame |
|---|---|
| "Corrected distance visual acuity" : the patient's central visual acuity, assessed subjectively. Timepoint: 1 week, 1, 3, and 6 months following corneal transplantation. Method of measurement: physical examination using the Logarithm of the Minimum Angle of Resolution (LogMAR) scale.;"Corneal edema" : corneal thickening resulting from the accumulation of extracellular fluid in the epithelial and stromal layers of the cornea. Timepoint: 1 week, 1, 3, and 6 months following corneal transplantation. Method of measurement: Slit-lamp examination, graded on a scale from 0 to 4.;"Final graft clarity" : Absence of corneal edema on slit-lamp examination at the final follow-up visit (six months after keratoplasty). Timepoint: 6 months following corneal transplantation. Method of measurement: Slit-lamp examination to assess the presence or absence of corneal edema.;"Time to complete graft re-epithelialization" : the time required for complete restoration of the integrity and continuity of the corneal graft epithelial layer. Timepoint: 1 week following corneal transplantation. Method of measurement: Slit-lamp examination with fluorescein staining to assess the presence or absence of corneal epithelial defects.;"Microbial keratitis" : proliferation and accumulation of microorganisms, including bacteria, viruses, or fungi, within the corneal layers. Timepoint: 1 week, 1, 3, and 6 months following corneal transplantation. Method of measurement: Slit-lamp examination to assess the presence or absence of microbial keratitis.;"Successful graft attachment" : successful attachment of the donor corneal lenticule to the host cornea without displacement or decentration. Timepoint: 1 week, 1, 3, and 6 months following corneal transplantation. Method of measurement: Slit-lamp examination to assess the presence or absence of successful endothelial graft attachment.;"Suture-related complications" : suture loosening, breakage or detachment, infectious abscess, toxic suture infiltration, or gia | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohamadjavad Babaki
Shahid Beheshti University of Medical Sciences
Outcome results
None listed