Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery

Study Overview
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Brief Summary
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The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.

Detailed Description
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Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by bilateral cloudy regions within hazy stroma and eventually severe visual impairment. Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in the production of keratan sulfate, which plays a role in the maintenance of corneal transparency. According to biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.

Official Title
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Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery

Conditions
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Macular Corneal Dystrophy

Intervention / Treatment
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* Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indications for penetrating keratoplasty low transparec of corneae low visual acuity Exclusion Criteria: active anterior segment pathology previous corneal or anterior segment surgery any infection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ReLex Smile surgery<br>The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser. | Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery<br>* Knowing that the most important element is damage of stroma we used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert, for example we remove 80 µm and we insert fresh corneal lenticule 90 µm with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.<br>* Other names: Relex smile surgery;|
| Other: fresh corneal lenticule implantation<br>Using VisuMax Femtosecond Laser we make intrastromal pocket incision 2-3 mm in periphery of cornea (Because the macular dystrophy is in the center more progressive) and 150 µm deep to put fresh corneal lenticule. After one month using VisuMax we create a flap using autologous serum with purpose to remove more dead keratocytes and adding live keratocytes with aim to regenerate the metabolism of cornea. | Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery<br>* Knowing that the most important element is damage of stroma we used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert, for example we remove 80 µm and we insert fresh corneal lenticule 90 µm with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.<br>* Other names: Relex smile surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of corneal transparency | Implanting fresh corneal lenticule we add more live stem cells and keratocytes to stabilize biomechanical stability of cornea. Also making flap and putting autologous serum after one month of implanting fresh corneal lenticule we removed more dead keratocytes from macula dystrophia and added more live keratocytes which contributed to the regeneration of the cornea. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of visual acuity | After implanting fresh corneal lenticule according to clarity of cornea visual acuity increased for 2-3 m and also softening symptoms of corneal dystrophy ex. dry eyes, sensitivity to light, pain in the eye, corneal erosion etc. | 12 months |