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Clinical Trials/NCT04594512
NCT04594512
Active, not recruiting
Not Applicable

Fresh Corneal Lenticule Implantation and Autologous Serum - New Approach in Treatment of Advanced Keratoconus Disease - Case Report

Eye Hospital Pristina Kosovo1 site in 1 country1 target enrollmentMay 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Keratoconus
Sponsor
Eye Hospital Pristina Kosovo
Enrollment
1
Locations
1
Primary Endpoint
Treatment of advanced keratoconus disease
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2019
End Date
May 8, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Eye Hospital Pristina Kosovo
Responsible Party
Principal Investigator
Principal Investigator

Dr. Faruk Semiz

Head of Ophthalmology Department

Eye Hospital Pristina Kosovo

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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