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

July 28, 2026 updated by: Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kosovo
      • Pristina, Kosovo, 10000
        • Eye Hospital Pristina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with irregular astigmatism
  • low visual acuity

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intrastromal Fresh Human Lenticule Implantation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of visual acuity
Time Frame: 12 months
Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye Hospital Pristina Kosovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 1, 2021

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EyeHPristina2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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