Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis (Relex-Smile)

Eye Hospital Pristina Kosovo

Status: Invitation-only

Conditions: Stromal Keratitis

Treatments: Other: Relex-Smile

Study type: Interventional

Funder types: Other

Identifiers

NCT05156151

EyehospitalPrishtina

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 21 to 46 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Stromal lenticule implantation for management of herpetic stromal keratitis

Other group

Description:

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.

Treatment:

Other: Relex-Smile