An interventional study of Relex-Smile in Stromal Keratitis, sponsored by Eye Hospital Pristina Kosovo. Enrolling by invitation at 1 site in Kosovo. Open to participants aged 21 Years to 46 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Eye Hospital Pristina Kosovo · Not applicable, Interventional, and Treatment
The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.
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.
108 studies on the registry are indexed under Keratitis; 19 are open to participants now.
This study's planned enrollment of 35 is below the median of 40 across 70 interventional studies indexed under Keratitis.
Browse Keratitis studies →Eye Hospital Pristina Kosovo is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: 12 months
Evaluation of visual acuity
Implantation of fresh corneal lenticule resulted in the visual acuity according to the clarity of cornea.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Jan 2020, 36 months.
Of 12 interventional studies with no phase under Keratitis, half reached primary completion within 20 months of starting (the median); a quarter within 5 and three quarters within 24. This study's 36 months is above that.
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Eye Hospital Pristina Kosovo