Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
- Conditions
- Progressive Disease of Corneae
- Registration Number
- NCT04848740
- Lead Sponsor
- Eye Hospital Pristina Kosovo
- Brief Summary
Stroma is a fibrous, tough, transparent and the thickest layer of the corneae. The stroma is composed of organised collagen, which maintains transparency. Keratocytes are located between the lamella collagen fibers and secrete an extracellular matrix, which includes collagen, proteoglycan, crystalline proteins to maintain corneal transparency.
- Detailed Description
Knowing the importance of stroma(90%) in function and anatomy of corneae (transparence, curvature, strength, protection) the inner eye structures from external environment, we have examined the role and function of stroma as a main factor of corneal thickness in implanting fresh corneal lenticule in progressive corneal disease.
We have studied that in many clinical cases where the corneal epithelium and endothelium are healthy and functioning, the cornea can still lose it's transparency by different corneal stromal pathologies (infection ,keratoconus, inflammation ,neurodegeneration and corneal dystrophies).
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- progressive corneal disease with thin corneal thickness
- corneal low transparenc
- low visual acuity
- active anterior segment pathology
- previous corneal or anterior segment surgery
- other infection etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Increase of corneal thickness 24 months Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Eye Hospital Pristina
Pristina, Kosovo
Eye Hospital PristinaPristina, Kosovo