NCT04642729

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Eye Hospital Pristina Kosovo · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Corneal Dystrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-01
• Completion: 2025-06-01
• First posted: 2020-11-24
• Last updated: 2024-02-20

Locations

1 site across 1 country: Kosovo