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

Primary Purpose

Irregular Astigmatism

Status
Active
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Intrastromal Fresh Human Lenticule Implantation
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irregular Astigmatism

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with irregular astigmatism
  • low visual acuity

Exclusion Criteria:

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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intrastromal Fresh Human Lenticule Implantation

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2021
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT04987060
Brief Title
Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (New Approach)
Official Title
Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (New Approach)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irregular Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Irregular astigmatism group
Masking
None (Open Label)
Masking Description
irregullar astigmatism group
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrastromal Fresh Human Lenticule Implantation
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intrastromal Fresh Human Lenticule Implantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase of visual acuity
Description
Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Decrease of irregular astigmatism
Description
In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with irregular astigmatism low visual acuity Exclusion Criteria: history of glaucoma retinal detachment history of ocular inflamation
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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