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Active, not recruitingNCT05123014Updated Jul 29, 2026

Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease

An interventional study of relex smile in Adenoviral Keratoconjunctivitis, sponsored by Eye Hospital Pristina Kosovo. Active, not recruiting at 1 site in Kosovo. Open to participants aged 24 Years to 43 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Feb 2018, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
24 Years to 43 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Adenoviral Keratoconjunctivitis

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03

In context

Keratoconjunctivitis

27 studies on the registry are indexed under Keratoconjunctivitis; 3 are open to participants now.

This study's enrollment of 45 is close to the median of 45 across 19 interventional studies indexed under Keratoconjunctivitis.

Browse Keratoconjunctivitis studies →

Lead sponsor

Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
24 Years to 43 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • low transparency of cornea
  • low visual acuity
  • recurrence keratitis

Exclusion criteria

Exclusion Criteria:

  • active anterior segment pathology
  • previous corneal or anterior segment surgery
  • any infection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Other
    ReLex Smile surgery

    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.

    Other: relex smile

Interventions

  • Otherrelex smile

    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.

06

What researchers measure

Primary outcomes

  1. Increasing corneal transparency

    Implanting lenticule with stromal stem cells ,live keratocytes and putting autologous serum to stabilize biomechanical stability of cornea.

    Time frame: 12 months

Secondary outcomes

  1. Increase of visual acuity

    Upon implanting fresh corneal lenticule according to clarity of cornea, uncorrected vision increased.

    Time frame: 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Feb 2019, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2021
First posted
Nov 17, 2021
StartActual
Feb 1, 2018
Primary completionActual
Feb 1, 2019
CompletionEst.
Feb 1, 2027
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05123014
Lead sponsor
Eye Hospital Pristina Kosovo
Responsible party
Dr. Faruk Semiz (Head of Ophthalmology Department, Eye Hospital Pristina Kosovo) — Principal investigator
First posted
Nov 17, 2021
Start date
Feb 1, 2018
Primary completion
Feb 1, 2019
Completion
Feb 1, 2027 (estimated)
Last update
Jul 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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