An interventional study of Fresh Corneal Lenticule Implantation using Relex-Smile Surgery in Macular Corneal Dystrophy, sponsored by Eye Hospital Pristina Kosovo. Enrolling by invitation at 1 site in Kosovo. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and Treatment
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.
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.
31 studies on the registry are indexed under Corneal Dystrophies, Hereditary; 9 are open to participants now.
This study's planned enrollment of 15 is below the median of 25 across 19 interventional studies indexed under Corneal Dystrophies, Hereditary.
Browse Corneal Dystrophies, Hereditary studies →Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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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
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
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.
Also known as: Relex smile surgery
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.
Time frame: 12 months
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.
Time frame: 12 months
Ran from Jun 2019 to primary completion in Jun 2020, 12 months.
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Corneal Dystrophies, Hereditary →
Eye Hospital Pristina Kosovo