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

Primary Purpose

Stromal Keratitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Relex-Smile
Sponsored by
Eye Hospital Pristina Kosovo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stromal Keratitis

Eligibility Criteria

21 Years - 46 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stromal lenticule implantation for management of herpetic stromal keratitis

Arm 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.

Outcomes

Primary Outcome Measures

Corneal transparency
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
Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.

Full Information

First Posted
October 25, 2021
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
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1. Study Identification

Unique Protocol Identification Number
NCT05156151
Brief Title
Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
Acronym
Relex-Smile
Official Title
Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stromal Keratitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stromal lenticule implantation for management of herpetic stromal keratitis
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Relex-Smile
Primary Outcome Measure Information:
Title
Corneal transparency
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of visual acuity
Description
Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: low transparenc of cornea low visual acuity recurrence of herpetic stromal keratitis Exclusion Criteria: previous corneal or anterior segment surgery any infection
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis

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