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Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

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: NCT04594512
Recruitment Status : Active, not recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Faruk Semiz, Eye Hospital Pristina Kosovo

Study Description
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Brief Summary:
The aim of our study is to investigate the feasibility and the effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients to implant in patients with keratoconus disease using VisuMax Femtosescond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary to improve visual acuity and reduces K-values and to show the autologous serum drop improve the recovery of patients with mild dry eye in keratoconus disease.

Condition or disease Intervention/treatment Phase
Keratoconus Keratoconus of Right Eye Keratoconus, Unstable, Right Eye Other: Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery Not Applicable

Detailed Description:
A 19-year-old female patient with keratoconus and chronic hydrops cornea referred to the cornea department of our clinic with thin cornea and hydrops in chronic stage and minimal dry eye symptoms. Minimum corneal pachymetry in the right eye was 378 µm as measured by optical coherence tomography(AS-OCT-Zeiss). Atlas corneal topography showed steep K-values 82.60 ax.37 and flat K 75.15 D ax 127 with -7.45 corneal astigmatism. Her best corrected visual acuity was 0.0.5 in right eye and 1.0 in the left eye. Slit lamp examination showed intense punctate epitheliopathy (Figure 1), tear film break-up time (TBUT) was measured as 7-8 sec and Schirmer test was 10 mm in right eye, and the other eye examinations were determined normally.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fresh Corneal Lenticule Implantation and Autologous Serum - New Approach in Treatment of Advanced Keratoconus Disease - Case Report
Actual Study Start Date : May 8, 2019
Actual Primary Completion Date : May 8, 2020
Estimated Study Completion Date : May 8, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
LENTICULE IMPLANTATION
The present study may suggest that this procedure safely, reliably, and effectively increases corneal thickness and improves visual acuity with no adverse effects. It may even provide new avenues in the treatment of corneal ectasia. Stem cells and live keratocytes are well organized based on cornea transparency and in anterior segment OCT.
 Other: Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery
A 19-year-old female patient with keratoconus and chronic hydrops cornea referred to the cornea department of our clinic with thin cornea and hydrops in chronic stage and minimal dry eye symptoms. Minimum corneal pachymetry in the right eye was 378 µm as measured by optical coherence tomography(AS-OCT-Zeiss). Atlas corneal topography showed steep K-values 82.60 ax.37 and flat K 75.15 D ax 127 with -7.45 corneal astigmatism. Her best corrected visual acuity was 0.0.5 in right eye and 1.0 in the left eye. Slit lamp examination showed intense punctate epitheliopathy (Figure 1), tear film break-up time (TBUT) was measured as 7-8 sec and Schirmer test was 10 mm in right eye, and the other eye examinations were determined normally
Other Name: ReLex Smile


Outcome Measures
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Primary Outcome Measures :
  1. Treatment of advanced keratoconus disease [ Time Frame: 12 months ]
    Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 20 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 18 years of age, male or female, of any race
  • Willingness and ability to follow all instructions and comply with schedule for follow-up visits
  • For females: Must not be pregnant

Exclusion Criteria:

  • Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
  • If female, pregnant
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): NCT04594512


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

Documents provided by Dr. Faruk Semiz, Eye Hospital Pristina Kosovo:
Informed Consent Form  [PDF] May 8, 2019

More Information
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Responsible Party: Dr. Faruk Semiz, Head of Ophthalmology Department, Eye Hospital Pristina Kosovo
ClinicalTrials.gov Identifier: NCT04594512    
Other Study ID Numbers: EyeHospitalP
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
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
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases