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
About this trial
This is an interventional treatment trial for Stromal Keratitis
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
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
NCT ID
NCT05156151
First Posted
October 25, 2021
Last Updated
February 13, 2023
Sponsor
Eye Hospital Pristina Kosovo
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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