Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ReLex-smile.
- Who it may be relevant to
- Registry conditions: Progressive Disease of Corneae. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kosovo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Device ReLex-smile
Using VisuMax femtosecond laser we created the stromal pocket with diameter of 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 130 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior inci
Primary outcome measures
- Increase of corneal thickness [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- progressive corneal disease with thin corneal thickness
- corneal low transparenc
- low visual acuity
Exclusion criteria
- active anterior segment pathology
- previous corneal or anterior segment surgery
- other infection etc.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Kosovo · 1 center
- Eye Hospital Pristina — Pristina
Identifiers
NCT: NCT04848740 · EyeHPristina1