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Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04591587
Enrollment
40
Registered
2020-10-19
Start date
2018-01-01
Completion date
2027-12-15
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus, Small Incision, Fresh Lenticule, Stromal Implantation, Stromal Stem Cells, Smile Surgery

Brief summary

CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

Detailed description

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

Interventions

PROCEDURELenticule 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

Sponsors

Dr. Faruk Semiz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Both models participated in this study. Model ages were from 20 up to 45

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Patients clinically diagnosed with progressive keratoconus

Exclusion criteria

* Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery

Design outcomes

Primary

MeasureTime frameDescription
Increase of corneal thickness at patients Lenticule group12 monthsIncrease of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes

Secondary

MeasureTime frameDescription
Improvement of visual acuity at patients Lenticule group12 monthsIncrease of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026