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

Irregular Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04987060
• Other study ID #: EyeHPristina2
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Eye Hospital Pristina Kosovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients with irregular astigmatism

• low visual acuity

Exclusion Criteria:

• history of glaucoma

• retinal detachment

• history of ocular inflamation

Related Conditions & MeSH terms

• Astigmatism
• Irregular Astigmatism

Intervention

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.

Locations

Country	Name	City	State
Kosovo	Eye Hospital Pristina	Pristina

Sponsors (1)

Lead Sponsor	Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of visual acuity	Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.	12 months
Secondary	Decrease of irregular astigmatism	In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.	12 months