Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery.
- Who it may be relevant to
- Registry conditions: Macular Corneal Dystrophy. Basic parameters: 20 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kosovo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery
Overview
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
- 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 ker
Primary outcome measures
- Increase of corneal transparency [Time frame: 12 months]
Secondary outcome measures (1)
- Increase of visual acuity [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Kosovo · 1 center
- Eye Hospital Pristina — Pristina
Identifiers
NCT: NCT04642729 · EyeHP