An interventional study of Intrastromal Fresh Human Lenticule Implantation in Irregular Astigmatism, sponsored by Eye Hospital Pristina Kosovo. Active, not recruiting at 1 site in Kosovo. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and Treatment
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.
Irregular astigmatism occurs when the curvature of the eye is pronounced in any direction, not just the center. The curve could be steeper towards the bottom than on top, or it could be any configuration in which the eye's surface area is uneven.
Irregular astigmatism usually can result from corneal degenerations(keratoconus,pellucid marginal degeneration,keratoglobus), corneal surgery or trauma.
Irregular astigmatism is still the main cause of decreased visual acuity after penetrating keratoplasty.
Our study present new therapeutic method and new technology to manage irregular astigmatism after PK. Knowing that the incidence of high and irregular astigmatism after PK is still a frequent complication and source of frustration for patients and corneal surgeons our study present an adequate surgical technique implanting intrastromal human corneal lenticule using SMILE for treatment of corneal irregular astigmatism after PK trying satisfy patients visual expectations.
417 studies on the registry are indexed under Astigmatism; 50 are open to participants now.
This study's planned enrollment of 24 is below the median of 55 across 325 interventional studies indexed under Astigmatism.
Browse Astigmatism studies →Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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The aim of this study is to investigate the effect of intrastromal fresh corneal lenticule implantation using Smile module surgery after PK with primary objective to increase visual acuity by reducing irregular astigmatism according to high K values. The stromal pocket diameter was 8 mm, 2mm super incision, 140-µm cap thickness and fresh lenticular implantation is performed.
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.
Increase of visual acuity
Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.
Time frame: 12 months
Decrease of irregular astigmatism
In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Mar 2021, 48 months.
Of 77 non-industry interventional studies with no phase under Astigmatism, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 48 months is above that.
Counting every sponsor, half of 183 studies reached it within 12 months; a quarter within 4 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Eye Hospital Pristina Kosovo