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NCT Number: NCT04594512

Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases Keratoconus of Right Eye Keratoconus, Unstable, Right Eye

Age range

19 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital Pristina

Pristina, 10000, Kosovo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: ReLex Smile

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Eye Hospital Pristina Kosovo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2026
First posted
Oct 20, 2020
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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