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Clinical Trials/NCT04987060
NCT04987060
Active, not recruiting
Not Applicable

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

Eye Hospital Pristina Kosovo1 site in 1 country24 target enrollmentMarch 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irregular Astigmatism
Sponsor
Eye Hospital Pristina Kosovo
Enrollment
24
Locations
1
Primary Endpoint
Increase of visual acuity
Status
Active, not recruiting
Last Updated
last year

Overview

Brief 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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2017
End Date
December 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Eye Hospital Pristina Kosovo
Responsible Party
Principal Investigator
Principal Investigator

Dr. Faruk Semiz

Head of Ophthalmology Department

Eye Hospital Pristina Kosovo

Eligibility Criteria

Inclusion Criteria

  • patients with irregular astigmatism
  • low visual acuity

Exclusion Criteria

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

Outcomes

Primary Outcomes

Increase of visual acuity

Time Frame: 12 months

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

Secondary Outcomes

  • Decrease of irregular astigmatism(12 months)

Study Sites (1)

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