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Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04594512
Enrollment
1
Registered
2020-10-20
Start date
2019-05-08
Completion date
2027-05-08
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERFresh 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

Sponsors

Eye Hospital Pristina Kosovo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 20 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment of advanced keratoconus disease12 monthsChange of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum

Countries

Kosovo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026