Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis

Not Applicable

• Conditions: Stromal Keratitis
• Interventions: Other: Relex-Smile

• Registration Number: NCT05156151
• Lead Sponsor: Eye Hospital Pristina Kosovo

Brief Summary

The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.

Detailed Description

Stromal keratitis is an infectious ocular disease of either necrotizing or non-necrotizing form, due to an HSV infection, and characterized by corneal stromal necrosis, inflammation, ulceration and infiltration by leukocytes.

In our study these early findings suggest that the use of corneal stromal lenticules with stromal stem cells and live keratocytes could be a safe and efficient treatment for stromal scar after herpetic keratitis, and excluding the recurrence of the disease by removing the corneal scar after herpetic infection using Smile and implanting the lenticule equal to the volume of the removed scar tissue.

Stromal lenticule implantation is relatively simple, low-cost and offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2020-01-01
• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• low transparenc of cornea
• low visual acuity
• recurrence of herpetic stromal keratitis

Exclusion Criteria

• previous corneal or anterior segment surgery
• any infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stromal lenticule implantation for management of herpetic stromal keratitis	Relex-Smile	The thickness of the herpetic stromal scar in the cornea is calculated in microns in OCT. Based on that extraction is performed using SMILE, a new lenticular stromal pocket is placed in the same volume. AS-OCT evaluated the corneal topography, glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were monitored during the follow-up period. During the three year follow-up period, no signs of recurrence or infections were detected in this patient.

Primary Outcome Measures

Name	Time	Method
Corneal transparency	12 months	Implantation of corneal stromal lenticules with stromal stem cells, live keratocytes and telocytes, stromal haze and scar have been successfully treated and stabilized the biomechanical stability of cornea in 87% of the patients which underwent this treatment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of visual acuity	12 months	Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo