Clincosm LogoSign in Get a demo

Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

Sponsor
Eye Hospital Pristina Kosovo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04594512
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery
 N/A

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

Study Type:
Interventional
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
Anticipated Study Completion Date :
May 8, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • ReLex Smile

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Treatment of advanced keratoconus disease [12 months]

      Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 20 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Eye Hospital Pristina Pristina Kosovo 10000

    Sponsors and Collaborators

    • Eye Hospital Pristina Kosovo

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Faruk Semiz, Head of Ophthalmology Department, Eye Hospital Pristina Kosovo
    ClinicalTrials.gov Identifier:
    NCT04594512
    Other Study ID Numbers:
    • EyeHospitalP
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keratoconus

    Study Results

    No Results Posted as of Jul 27, 2022