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

Not Applicable

Active, not recruiting

• Conditions: Irregular Astigmatism
• Interventions: Device: Intrastromal Fresh Human Lenticule Implantation

• Registration Number: NCT04987060
• Lead Sponsor: Eye Hospital Pristina Kosovo

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2021-03-01
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-03
• Status Verified: 2024-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• patients with irregular astigmatism
• low visual acuity

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intrastromal Fresh Human Lenticule Implantation	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.

Primary Outcome Measures

Name	Time	Method
Increase of visual acuity	12 months	Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.

Secondary Outcome Measures

Name	Time	Method
Decrease of irregular astigmatism	12 months	In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo