Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule

NAActive, not recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

April 1, 2018

Primary Completion Date

April 1, 2020

Study Completion Date

February 1, 2027

Conditions
PseudophakiaHypermetropiaMyopia
Interventions
OTHER

FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION

VisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule. The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 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. Current orientation was marked with a sterile skin marker. The lenticule was positioned around the marked center of the cone and flattened out from the surface using a blunt spatula.

Trial Locations (1)

10000

Eye Hospital Pristina, Pristina

All Listed Sponsors
lead

Eye Hospital Pristina Kosovo

OTHER

NCT04692012 - Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule | Biotech Hunter | Biotech Hunter