Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04594512
• Other study ID #: EyeHospitalP
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: May 8, 2024

Study information

• Verified date: September 2023
• Source: Eye Hospital Pristina Kosovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: May 8, 2024
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus
• Keratoconus of Right Eye
• Keratoconus, Unstable, Right Eye

Intervention

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

Locations

Country	Name	City	State
Kosovo	Eye Hospital Pristina	Pristina

Sponsors (1)

Lead Sponsor	Collaborator
Eye Hospital Pristina Kosovo

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment of advanced keratoconus disease	Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum	12 months