NCT05156151

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

October 25, 2021

Last Update Submit

February 15, 2024

Conditions

Stromal Keratitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Evaluation of visual acuity

    12 months

Study Arms (1)

Stromal lenticule implantation for management of herpetic stromal keratitis

OTHER

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

Interventions

Relex-SmileOTHER
Stromal lenticule implantation for management of herpetic stromal keratitis

Eligibility Criteria

Age21 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • low transparenc of cornea
  • low visual acuity
  • recurrence of herpetic stromal keratitis

You may not qualify if:

  • previous corneal or anterior segment surgery
  • any infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Ophthalmology Department

Study Record Dates

First Submitted

October 25, 2021

First Posted

December 14, 2021

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2025

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KO(1)