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

Eye Hospital Pristina Kosovo

Status: Active, not recruiting

Conditions: Irregular Astigmatism

Treatments: Device: Intrastromal Fresh Human Lenticule Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04987060

EyeHPristina2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with irregular astigmatism
• low visual acuity

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Intrastromal Fresh Human Lenticule Implantation

Other group

Description:

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.

Treatment:

Device: Intrastromal Fresh Human Lenticule Implantation