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

February 15, 2024 updated by: Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kosovo
      • Pristina, Kosovo, 10000
        • Eye Hospital Pristina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal transparency
Time Frame: 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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye Hospital Pristina Kosovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EyehospitalPrishtina

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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