Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

Not Applicable

Active, not recruiting

• Conditions: Keratoconus; Keratoconus of Right Eye; Keratoconus, Unstable, Right Eye
• Interventions: Other: Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery

• Registration Number: NCT04594512
• Lead Sponsor: Eye Hospital Pristina Kosovo

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.

Study Timeline

• Study Start: 2019-05-08
• Primary Completion: 2020-05-08
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Completion: 2026-05-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LENTICULE IMPLANTATION	Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery	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.

Primary Outcome Measures

Name	Time	Method
Treatment of advanced keratoconus disease	12 months	Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo