Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Study Overview
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Brief Summary
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CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

Detailed Description
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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

Official Title
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Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Conditions
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Keratoconus

Intervention / Treatment
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* Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Both models participated in this study. Model ages were from 20 up to 45
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smile Group<br>Twenty patients (20) underwent SMILE surgery (first group) | Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery<br>* 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<br>|
| Active Comparator: Lenticule Group<br>Twenty patients (20) underwent lenticule implantation (second group) | Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of corneal thickness at patients Lenticule group | Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of visual acuity at patients Lenticule group | Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keratoconus, Small Incision, Fresh Lenticule, Stromal Implantation, Stromal Stem Cells, Smile Surgery