Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile

NAEnrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

February 1, 2026

Study Completion Date

February 1, 2027

Conditions
Progressive Disease of Corneae
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 incision. Incision position changed according to the position of the highest K values We noticed during intervention that implantation of fresh lenticule depends from corneal thickness, for example if c.th.is 300-400 μm we implanted 1/2 stroma, if c.th.is 400 μm or more we implanted 1/3 stroma Example: if corneal thickness is 300 μm we implanted 150 μm (becoming 450 μm) we added more stroma due to more live keratocytes and stromal steam cells, aiming to overcome dead and non-functional keratocytes

Trial Locations (1)

10000

Eye Hospital Pristina, Pristina

All Listed Sponsors
lead

Eye Hospital Pristina Kosovo

OTHER