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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Progressive Disease of Corneae
• Intervention / Treatment: Device: ReLex-smile

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kosovo
  • Pristina, Kosovo, 10000
    • Eye Hospital Pristina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: FRESH CORNEAL LENTICULE IMPLANTATION; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase of corneal thickness	Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes	24 months

Collaborators and Investigators

• Sponsor: Eye Hospital Pristina Kosovo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Disease Progression; Corneal Diseases
• Other Study ID Numbers: EyeHPristina1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No