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

NCT04642729 | Enrolling By Invitation

• 1 other identifier: EyeHP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Corneal Dystrophy

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Increase of visual acuity

  12 months

Study Arms (2)

ReLex Smile surgery

OTHER

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

fresh corneal lenticule implantation

OTHER

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

Interventions

Fresh Corneal Lenticule Implantation using Relex-Smile Surgery PROCEDURE

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

ReLex Smile surgery; fresh corneal lenticule implantation

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• indications for penetrating keratoplasty
• low transparec of corneae
• low visual acuity

You may not qualify if:

• active anterior segment pathology
• previous corneal or anterior segment surgery
• any infection

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 24, 2020
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

KO (1)