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

NCT04987060 | Active Not Recruiting

• 1 other identifier: EyeHPristina2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Irregular Astigmatism

Outcome Measures

Primary Outcomes (1)

• Increase of visual acuity

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

  12 months

Secondary Outcomes (1)

• Decrease of irregular astigmatism

  12 months

Study Arms (1)

Intrastromal Fresh Human Lenticule Implantation

OTHER

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

Interventions

Intrastromal Fresh Human Lenticule Implantation DEVICE

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.

Intrastromal Fresh Human Lenticule Implantation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with irregular astigmatism
• low visual acuity

You may not qualify if:

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

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: irregullar astigmatism group
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Model Details: Irregular astigmatism group

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: March 1, 2017
• Primary Completion: March 1, 2021
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2024-02

Locations

KO (1)