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ACTIVE NOT RECRUITING
NCT04987060
NA

Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (new Approach)

Sponsor: Eye Hospital Pristina Kosovo

View on ClinicalTrials.gov

Summary

The aim of the study is to present the effect of implanting intrastromal fresh corneal lenticule by SMILE surgery as a new method-approach to correct the corneal shape on purpose to reduce irregular astigmatism and increasing visual acuity after penetrating keratoplasty.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2017-03-01

Completion Date

2027-12-01

Last Updated

2025-02-26

Healthy Volunteers

No

Interventions

DEVICE

Intrastromal Fresh Human Lenticule Implantation

The stromal pocket diameter was set 8.0 mm and cap thickness was set to 140 μm from corneal surface and a 2mm 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 2 mm superior incision. Incision position changed according to the position of the highest K values.

Locations (1)

Eye Hospital Pristina

Pristina, Kosovo