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Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Primary Purpose

Keratoconus

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
Sponsored by
Dr. Faruk Semiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Small Incision, Fresh Lenticule, Stromal Implantation, Stromal Stem Cells, Smile Surgery

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Hospital Pristina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Smile Group

Lenticule Group

Arm Description

Twenty patients (20) underwent SMILE surgery (first group)

Twenty patients (20) underwent lenticule implantation (second group)

Outcomes

Primary Outcome Measures

Increase of corneal thickness at patients Lenticule group
Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes

Secondary Outcome Measures

Improvement of visual acuity at patients Lenticule group
Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness

Full Information

First Posted
June 15, 2020
Last Updated
February 13, 2023
Sponsor
Dr. Faruk Semiz
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1. Study Identification

Unique Protocol Identification Number
NCT04591587
Brief Title
Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
Official Title
Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Faruk Semiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Small Incision, Fresh Lenticule, Stromal Implantation, Stromal Stem Cells, Smile Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Both models participated in this study. Model ages were from 20 up to 45
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smile Group
Arm Type
Active Comparator
Arm Description
Twenty patients (20) underwent SMILE surgery (first group)
Arm Title
Lenticule Group
Arm Type
Active Comparator
Arm Description
Twenty patients (20) underwent lenticule implantation (second group)
Intervention Type
Procedure
Intervention Name(s)
Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Increase of corneal thickness at patients Lenticule group
Description
Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement of visual acuity at patients Lenticule group
Description
Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo

12. IPD Sharing Statement

Plan to Share IPD
No

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Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

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