Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report
Primary Purpose
Keratoconus, Keratoconus of Right Eye, Keratoconus, Unstable, Right Eye
Status
Active
Phase
Not Applicable
Locations
Kosovo
Study Type
Interventional
Intervention
Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility 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
Sites / Locations
- Eye Hospital Pristina
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
LENTICULE IMPLANTATION
Arm Description
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.
Outcomes
Primary Outcome Measures
Treatment of advanced keratoconus disease
Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum
Secondary Outcome Measures
Full Information
NCT ID
NCT04594512
First Posted
October 1, 2020
Last Updated
September 5, 2023
Sponsor
Eye Hospital Pristina Kosovo
1. Study Identification
Unique Protocol Identification Number
NCT04594512
Brief Title
Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report
Official Title
Fresh Corneal Lenticule Implantation and Autologous Serum - New Approach in Treatment of Advanced Keratoconus Disease - Case Report
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
May 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye Hospital Pristina Kosovo
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Keratoconus of Right Eye, Keratoconus, Unstable, Right Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LENTICULE IMPLANTATION
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery
Other Intervention Name(s)
ReLex Smile
Intervention 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
Primary Outcome Measure Information:
Title
Treatment of advanced keratoconus disease
Description
Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Eye Hospital Pristina
City
Pristina
ZIP/Postal Code
10000
Country
Kosovo
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report
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