Adenoviral KeratoconjunctivitisNCT05123014
Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
A study testing relex smile in people with Adenoviral Keratoconjunctivitis, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial summary
Adenoviral keratitis(caused by adenovirus) is one of the most frequently diagnosed eye diseases. Most of these infections have symptoms like (Ocular itchiness and irritation, chemosis (conjunctival edema),photophobia, epiphora, foreign body sensation, epithelial keratitis etc.Adenoviral subepithelial infiltration is… Read more about this study
- Who is it for?
- Ages 24 to 43 years
- Conditions the study is for
- Adenoviral Keratoconjunctivitis
- What is being tested?
- relex smile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Feb 2018to 1 Feb 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 24 to 43 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- low transparency of cornea
- low visual acuity
- recurrence keratitis
Who cannot join
- active anterior segment pathology
- previous corneal or anterior segment surgery
- any infection
Trial locations and contacts
1 site in 1 country.
About this study
Adenoviral keratitis(caused by adenovirus) is one of the most frequently diagnosed eye diseases. Most of these infections have symptoms like (Ocular itchiness and irritation, chemosis (conjunctival edema),photophobia, epiphora, foreign body sensation, epithelial keratitis etc.Adenoviral subepithelial infiltration is one of the most difficult complication to treat. Our purpose is to evaluate corneal transparency, recurrence, and visual acuity in patients with adenoviral subepithelial infiltration by first removing the infiltrative stroma with a smile and implanting the same volume of fresh lenticule in the prepared stromal pocket.
Read the detailed description
Our treatment of adenoviral keratitis using lenticule implantation and autologus serum it has been applied to patients who have received medical treatment(Antiviral medications, topical corticosteroids ,compresses, artificial tears, and topical cycloplegic) for a long time but have not been successful.
In OCT, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with Small Incision Lenticule Extraction( SMILE )and fresh lenticule implanted stromal in the same volume. AS-OCT was evaluated using corneal topography and glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were recorded during the follow-up period.
The patients were followed for one year. No complications were observed in the patients. After the operation, there was an increase in satisfaction and vision. They returned to their daily lives very quickly.
Postoperatively, uncorrected vision increased to 6 lines in 12 eyes, seven lines in 11 eyes, and eight lines in 3 eyes.
- Conditions
- Adenoviral Keratoconjunctivitis
- 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
In OCT, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with Small Incision Lenticule Extraction( SMILE )and fresh lenticule implanted stromal in the same volume.
| Study group | Role | What they receive |
|---|---|---|
| ReLex Smile surgery | Other | Fresh Corneal Lenticule Implantation using Relex-Smile Surgery We used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with adenoviral keratitis. Receives: Other: relex smile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing corneal transparency
Implanting lenticule with stromal stem cells ,live keratocytes and putting autologous serum to stabilize biomechanical stability of cornea.
Measured: 12 months
Secondary outcomes (1)
Increase of visual acuity
Upon implanting fresh corneal lenticule according to clarity of cornea, uncorrected vision increased.
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 posted17 Nov 2021
- Study start1 Feb 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral KeratoconjunctivitisStudies 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
- Model description
- LENTICULE IMPLANTATION AND AUTOLOGOUS SERUM NEW APPROACH IN TREATMENT OF ADENOVIRAL KERATITIS DISEASE
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
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
- NCT05123014
- Sponsor's protocol ID
- EyeHPristina 1
- Status last verified
- Jul 2026
- First submitted
- 5 Nov 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
- Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
- ClinicalTrials.gov ID
- NCT05123014
- Acronym / sponsor ID
- EyeHPristina 1
- Conditions
- Adenoviral Keratoconjunctivitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eye Hospital Pristina KosovoUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 Nov 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.
Adenoviral keratitis(caused by adenovirus) is one of the most frequently diagnosed eye diseases. Most of these infections have symptoms like (Ocular itchiness and irritation, chemosis (conjunctival edema),photophobia, epiphora, foreign body sensation, epithelial keratitis etc.Adenoviral subepithelial infiltration is one of the most difficult complication to treat. Our purpose is to evaluate corneal transparency, recurrence, and visual acuity in patients with adenoviral subepithelial infiltration by first removing the infiltrative stroma with a smile and implanting the same volume of fresh lenticule in the prepared stromal pocket.
Detailed description
Our treatment of adenoviral keratitis using lenticule implantation and autologus serum it has been applied to patients who have received medical treatment(Antiviral medications, topical corticosteroids ,compresses, artificial tears, and topical cycloplegic) for a long time but have not been successful.
In OCT, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with Small Incision Lenticule Extraction( SMILE )and fresh lenticule implanted stromal in the same volume. AS-OCT was evaluated using corneal topography and glass-corrected best visual acuity (BSCVA) measurements and electron microscopy. Postoperative complications were recorded during the follow-up period.
The patients were followed for one year. No complications were observed in the patients. After the operation, there was an increase in satisfaction and vision. They returned to their daily lives very quickly.
Postoperatively, uncorrected vision increased to 6 lines in 12 eyes, seven lines in 11 eyes, and eight lines in 3 eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- LENTICULE IMPLANTATION AND AUTOLOGOUS SERUM NEW APPROACH IN TREATMENT OF ADENOVIRAL KERATITIS DISEASE
| Arm | Type | Receives |
|---|---|---|
| ReLex Smile surgery | Other | Other: relex smileFresh Corneal Lenticule Implantation using Relex-Smile Surgery We used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with adenoviral keratitis. |
Who may qualify
- Ages
- 24 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- low transparency of cornea
- low visual acuity
- recurrence keratitis
Key exclusion criteria (3 listed)
- active anterior segment pathology
- 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 smileIn OCT, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with Small Incision Lenticule Extraction( SMILE )and fresh lenticule implanted stromal in the same volume. | Other | ReLex Smile surgery |
Primary outcome
Increasing corneal transparency
Time frame: 12 months
Implanting lenticule with stromal stem cells ,live keratocytes and putting autologous serum to stabilize biomechanical stability of cornea.
1 secondary outcome
Increase 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
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. This study is not recruiting at the moment.
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 Adenoviral Keratoconjunctivitis, 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 3 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: under way, not looking for participants, 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?
Increasing 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.