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NCT Number: NCT04987060

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Irregular Astigmatism

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital Pristina

Pristina, 10000, Kosovo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with irregular astigmatism
  • low visual acuity

Exclusion criteria

  • history of glaucoma
  • retinal detachment
  • history of ocular inflamation

Treatment and study plan

Intrastromal Fresh Human Lenticule Implantation

Device

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.

Primary outcomes

  1. Increase of visual acuity

    Time frame: 12 months

    Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.

Secondary outcomes

  1. Decrease of irregular astigmatism

    Time frame: 12 months

    In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.

Sponsors and collaborators

Lead sponsor

Eye Hospital Pristina Kosovo

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2027
First posted
Aug 3, 2021
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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