An interventional study of Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery in Keratoconus, sponsored by Dr. Faruk Semiz. Enrolling by invitation at 1 site in Kosovo. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Dr. Faruk Semiz · Not applicable, Interventional, and Treatment
CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY
Purpose:
The purpose of our study is to investigate the feasibility and effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients, in order to implant in patients with keratocouns disease using VisuMax Femtosecond laser - Smile module surgery which primary objective in to increase central corneal thickness and secondary objective is to improve visual acuity and reducing K-values.
Methods:
All the patients were clinically diagnosed with progressive keratoconus. Twenty (20) patients underwent SMILE surgery (first group), and twenty (20) patients underwent lenticule implantation (second group). Visual acuity, corneal topography, electron microscop,anterior segment optical coherence tomography, were analyzed.
Outcome:
Central corneal thickness were improved at the same day of surgery and vision started to improve at first week postoperatively in the second group (lenticule implant group). Corneal topography showed a statistically significant decrease in the anterior K1 and K2. All the grafts from both groups were clearly visible by anterior segment optical coherence tomography observation and electron microscope. The central corneal thickness was stable during the 6-month study period. No complications were observed during short term follow-up.
Opinion:
In our opinion, the present study may suggest that this procedure, using fresh lenticule with stromal stem cells and live keratocites is safe, reliable, and effectively increases corneal thickness and improves visual acuity with no adverse effects, which may provide new avenues in the treatment of corneal ectasia.
Key Words:
keratoconus,small incision,fresh lenticule, stromal implantation,stromal stem cells, Smile surgery
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 205 interventional studies indexed under Keratoconus.
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Exclusion Criteria:
Twenty patients (20) underwent SMILE surgery (first group)
Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
Twenty patients (20) underwent lenticule implantation (second group)
Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery using VisuMax Femtosecond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary objective to improve visual acuity and reduces K-values
Increase of corneal thickness at patients Lenticule group
Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes
Time frame: 12 months
Improvement of visual acuity at patients Lenticule group
Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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