Stromal KeratitisRelex-SmileNCT05156151
Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
A study testing Relex-Smile in people with Stromal Keratitis, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial summary
The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis. Read more about this study
- Who is it for?
- Ages 21 to 46 years
- Conditions the study is for
- Stromal Keratitis
- What is being tested?
- Relex-Smile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Jan 2017to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 46 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- low transparenc of cornea
- low visual acuity
- recurrence of herpetic stromal keratitis
Who cannot join
- previous corneal or anterior segment surgery
- any infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.
Read the 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.
- Conditions
- Stromal Keratitis
- Being tested
- Relex-Smile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relex-SmileOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Relex-Smile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Evaluation of visual acuity
Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stromal KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Hospital Pristina Kosovo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156151
- Sponsor's protocol ID
- EyehospitalPrishtina
- Acronym
- Relex-Smile
- Status last verified
- Jul 2026
- First submitted
- 25 Oct 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
- ClinicalTrials.gov ID
- NCT05156151
- Acronym / sponsor ID
- Relex-Smile / EyehospitalPrishtina
- Conditions
- Stromal Keratitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Eye Hospital Pristina KosovoUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stromal lenticule implantation for management of herpetic stromal keratitis | Other | Other: Relex-SmileThe 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. |
Who may qualify
- Ages
- 21 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- low transparenc of cornea
- low visual acuity
- recurrence of herpetic stromal keratitis
Key exclusion criteria (2 listed)
- previous corneal or anterior segment surgery
- any infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relex-Smile | Other | Stromal lenticule implantation for management of herpetic stromal keratitis |
Primary outcome
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.
1 secondary outcome
Evaluation of visual acuity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relex-Smile in people with Stromal Keratitis, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal transparency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.