Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (New Approach)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
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.
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Outcome Measures
Primary Outcome Measures
- Increase of visual acuity [12 months]
Using intrastromal fresh corneal lenticule resulted in the increase of the visual acuity.
Secondary Outcome Measures
- Decrease of irregular astigmatism [12 months]
In order to stabilize irregular astigmatism and reduce K-values, the intrastromal fresh corneal lenticule was implanted.
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients with irregular astigmatism
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low visual acuity
Exclusion Criteria:
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history of glaucoma
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retinal detachment
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history of ocular inflamation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eye Hospital Pristina | Pristina | Kosovo | 10000 |
Sponsors and Collaborators
- Eye Hospital Pristina Kosovo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EyeHPristina2