Relex-Smile: Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis

Sponsor

Eye Hospital Pristina Kosovo (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05156151

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stromal Keratitis	Other: Relex-Smile	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Stromal lenticule implantation for management of herpetic stromal keratitis 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.	Other: Relex-Smile

Arm

Intervention/Treatment

Other: Stromal lenticule implantation for management of herpetic stromal keratitis

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.

Other: Relex-Smile

Outcome Measures

Primary Outcome Measures

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

Evaluation of visual acuity [12 months]
Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 46 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Hospital Pristina	Pristina		Kosovo	10000

Sponsors and Collaborators

Eye Hospital Pristina Kosovo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Faruk Semiz, Head of Ophthalmology Department, Eye Hospital Pristina Kosovo

ClinicalTrials.gov Identifier:

NCT05156151

Other Study ID Numbers:

EyehospitalPrishtina

First Posted:

Dec 14, 2021

Last Update Posted:

Dec 14, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Keratitis

Study Results

No Results Posted as of Dec 14, 2021