Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile

NAEnrolling by invitationINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

June 1, 2016

Primary Completion Date

June 1, 2018

Study Completion Date

June 1, 2026

Conditions
PseudophakiaMyopiaHyperopia
Interventions
PROCEDURE

Relex Smile

Procedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was min -0.75D.The optical zone (lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker(ViscotMedster).

PROCEDURE

Relex smile with fresh corneal 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.~In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticular implantation should be performed according to the low K values."

Trial Locations (1)

10000

Eye Hospital Pristina, Pristina

All Listed Sponsors
lead

Eye Hospital Pristina Kosovo

OTHER