Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05156151

Acronym

Relex-Smile

Enrollment

Registered

2021-12-14

Start date

2017-01-01

Completion date

2027-01-01

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stromal Keratitis

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.

Interventions

OTHERRelex-Smile

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 46 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* previous corneal or anterior segment surgery * any infection

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Evaluation of visual acuity	12 months	Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026