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ENROLLING BY INVITATION
NCT04712318
NA

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

Sponsor: Eye Hospital Pristina Kosovo

View on ClinicalTrials.gov

Summary

Successful treatment of residual refraction 6 months after IOL Implantation with Relex-Smile.

Official title: Succesful Treatment of Residual Refraction Errors (Myopic and Hyperopic) 6 Months After Trifocal IOL Implantation With Relex-Smile

Key Details

Gender

All

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2016-06-01

Completion Date

2026-06-01

Last Updated

2024-08-27

Healthy Volunteers

No

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.

Locations (1)

Eye Hospital Pristina

Pristina, Kosovo