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

Not Applicable

• Conditions: Progressive Disease of Corneae
• Interventions: Device: ReLex-smile

• Registration Number: NCT04848740
• Lead Sponsor: Eye Hospital Pristina Kosovo

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).

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FRESH CORNEAL LENTICULE IMPLANTATION	ReLex-smile	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.

Primary Outcome Measures

Name	Time	Method
Increase of corneal thickness	24 months	Increase of corneal central thickness using human fresh corneal lenticule with stromal stem cells and live keratocytes

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo