Fresh Corneal Lenticule Implantation and Autologous Serum - Case Report

NCT ID: NCT04594512

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-08
• Study Completion Date: 2026-05-08

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LENTICULE IMPLANTATION

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.

Group Type: OTHER

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

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

ReLex Smile

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eye Hospital Pristina Kosovo

OTHER

Sponsor Role: lead

Responsible Party

Dr. Faruk Semiz

Head of Ophthalmology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye Hospital Pristina

Pristina, , Kosovo

Countries

Kosovo

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

EyeHospitalP

Identifier Type: -

Identifier Source: org_study_id