Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
NCT ID: NCT04591587
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
40 participants
INTERVENTIONAL
2018-01-01
2024-12-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Smile Group
Twenty patients (20) underwent SMILE surgery (first group)
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
Lenticule Group
Twenty patients (20) underwent lenticule implantation (second group)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
40 Years
ALL
No
Sponsors
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Dr. Faruk Semiz
OTHER
Responsible Party
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Dr. Faruk Semiz
Principal Doctor
Locations
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Eye Hospital Pristina
Pristina, , Kosovo
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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EyeHPristina
Identifier Type: -
Identifier Source: org_study_id
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