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Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04591587
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2020
Last Update Posted : August 19, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Faruk Semiz, Eye Hospital Pristina Kosovo

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

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Both models participated in this study. Model ages were from 20 up to 45
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Estimated Study Completion Date : June 15, 2024

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Smile Group
Twenty patients (20) underwent SMILE surgery (first 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
Active Comparator: Lenticule Group
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


Outcome Measures
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Primary Outcome Measures :
  1. Increase of corneal thickness at patients Lenticule group [ Time Frame: 12 months ]
    Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes


Secondary Outcome Measures :
  1. Improvement of visual acuity at patients Lenticule group [ Time Frame: 12 months ]
    Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591587


Locations
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Kosovo
Eye Hospital Pristina
Pristina, Kosovo, 10000
Sponsors and Collaborators
Dr. Faruk Semiz
  Study Documents (Full-Text)

Documents provided by Dr. Faruk Semiz, Eye Hospital Pristina Kosovo:
Informed Consent Form  [PDF] June 15, 2019

More Information
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Responsible Party: Dr. Faruk Semiz, Principal Doctor, Eye Hospital Pristina Kosovo
ClinicalTrials.gov Identifier: NCT04591587    
Other Study ID Numbers: EyeHPristina
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: August 19, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Faruk Semiz, Eye Hospital Pristina Kosovo:
Keratoconus
Small Incision
Fresh Lenticule
 Stromal Implantation
Stromal Stem Cells
Smile Surgery
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases