Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

NCT04594512 | Active Not Recruiting

• 1 other identifier: EyeHospitalP
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus; Keratoconus of Right Eye; Keratoconus, Unstable, Right Eye

Outcome Measures

Primary Outcomes (1)

• Treatment of advanced keratoconus disease

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

  12 months

Study Arms (1)

LENTICULE IMPLANTATION

OTHER

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

Interventions

Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery OTHER

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

Also known as: ReLex Smile

LENTICULE IMPLANTATION

Eligibility Criteria

• Age: 19 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
• If female, pregnant

Sponsors & Collaborators

• Eye Hospital Pristina Kosovo: lead

Study Sites (1)

Eye Hospital Pristina

Pristina, 10000, Kosovo

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 20, 2020
• Study Start: May 8, 2019
• Primary Completion: May 8, 2020
• Study Completion (Estimated): May 8, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)