Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Macular Corneal Dystrophy
- Sponsor
- Eye Hospital Pristina Kosovo
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Increase of corneal transparency
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Dr. Faruk Semiz
Head of Ophthalmology Department
Eye Hospital Pristina Kosovo
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
Outcomes
Primary Outcomes
Increase of corneal transparency
Time Frame: 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 Outcomes
- Increase of visual acuity(12 months)