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

Progressive Disease of Corneae Clinical Trial

— Relex-Smile  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04848740
• Other study ID #: EyeHPristina1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Eye Hospital Pristina Kosovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Diseases
• Disease Progression
• Progressive Disease of Corneae

Intervention

Device:
• ReLex-smile
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

Locations

Country	Name	City	State
Kosovo	Eye Hospital Pristina	Pristina

Sponsors (1)

Lead Sponsor	Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of corneal thickness	Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes	24 months