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Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile (Relex-Smile)

Primary Purpose

Progressive Disease of Corneae

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
ReLex-smile
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Disease of Corneae

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • progressive corneal disease with thin corneal thickness
  • corneal low transparenc
  • low visual acuity

Exclusion Criteria:

  • active anterior segment pathology
  • previous corneal or anterior segment surgery
  • other infection etc.

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FRESH CORNEAL LENTICULE IMPLANTATION

Arm Description

The aim in our study is to describe the importance of stroma as criteria of corneal thickness at implanting human fresh corneal lenticule in progressive corneal disease. We have conclude that every biomechanical instability of corneal stroma function(abnormal increase collagen activity,decrease proteinase inhibitors,excessive premature keratocyte apoptosis) describe the role of stroma in corneal thickness.

Outcomes

Primary Outcome Measures

Increase of corneal thickness
Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes

Secondary Outcome Measures

Full Information

First Posted
April 14, 2021
Last Updated
September 5, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT04848740
Brief Title
Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
Acronym
Relex-Smile
Official Title
Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 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
Stroma is a fibrous, tough, transparent and the thickest layer of the corneae. The stroma is composed of organised collagen, which maintains transparency. Keratocytes are located between the lamella collagen fibers and secrete an extracellular matrix, which includes collagen, proteoglycan, crystalline proteins to maintain corneal transparency.
Detailed Description
Knowing the importance of stroma(90%) in function and anatomy of corneae (transparence, curvature, strength, protection) the inner eye structures from external environment, we have examined the role and function of stroma as a main factor of corneal thickness in implanting fresh corneal lenticule in progressive corneal disease. We have studied that in many clinical cases where the corneal epithelium and endothelium are healthy and functioning, the cornea can still lose it's transparency by different corneal stromal pathologies (infection ,keratoconus, inflammation ,neurodegeneration and corneal dystrophies).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Disease of Corneae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FRESH CORNEAL LENTICULE IMPLANTATION
Arm Type
Other
Arm Description
The aim in our study is to describe the importance of stroma as criteria of corneal thickness at implanting human fresh corneal lenticule in progressive corneal disease. We have conclude that every biomechanical instability of corneal stroma function(abnormal increase collagen activity,decrease proteinase inhibitors,excessive premature keratocyte apoptosis) describe the role of stroma in corneal thickness.
Intervention Type
Device
Intervention Name(s)
ReLex-smile
Intervention Description
Using VisuMax femtosecond laser we created the stromal pocket with diameter of 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 130 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision. Incision position changed according to the position of the highest K values We noticed during intervention that implantation of fresh lenticule depends from corneal thickness, for example if c.th.is 300-400 μm we implanted 1/2 stroma, if c.th.is 400 μm or more we implanted 1/3 stroma Example: if corneal thickness is 300 μm we implanted 150 μm (becoming 450 μm) we added more stroma due to more live keratocytes and stromal steam cells, aiming to overcome dead and non-functional keratocytes
Primary Outcome Measure Information:
Title
Increase of corneal thickness
Description
Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: progressive corneal disease with thin corneal thickness corneal low transparenc low visual acuity Exclusion Criteria: active anterior segment pathology previous corneal or anterior segment surgery other infection etc.
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Human Fresh Corneal Lenticule Implantation Criteria in Progressive Corneal Disease Using Relex-Smile

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