Macular Corneal Dystrophy
Conditions
Brief summary
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
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.
Interventions
PROCEDUREFresh 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.
Sponsors
Eye Hospital Pristina Kosovo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase of corneal transparency | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase of visual acuity | 12 months | 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. |
Countries
Kosovo
Outcome results
None listed