Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery
Primary Purpose
Macular Corneal Dystrophy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Fresh Corneal Lenticule Implantation using Relex-Smile Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Macular Corneal Dystrophy
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
Sites / Locations
- Eye Hospital Pristina
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ReLex Smile surgery
fresh corneal lenticule implantation
Arm Description
The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Increase of visual acuity
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.
Full Information
NCT ID
NCT04642729
First Posted
November 20, 2020
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
1. Study Identification
Unique Protocol Identification Number
NCT04642729
Brief Title
Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery
Official Title
Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Corneal Dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ReLex Smile surgery
Arm Type
Other
Arm Description
The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser.
Arm Title
fresh corneal lenticule implantation
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fresh Corneal Lenticule Implantation using Relex-Smile Surgery
Other Intervention Name(s)
Relex smile surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase of corneal transparency
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Increase of visual acuity
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo
12. IPD Sharing Statement
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Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery
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