Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Not Applicable

• Conditions: Keratoconus
• Interventions: Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery

• Registration Number: NCT04591587
• Lead Sponsor: Dr. Faruk Semiz

Brief Summary

CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

Detailed Description

Purpose:

The purpose of our study is to investigate the feasibility and effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients, in order to implant in patients with keratocouns disease using VisuMax Femtosecond laser - Smile module surgery which primary objective in to increase central corneal thickness and secondary objective is to improve visual acuity and reducing K-values.

Methods:

All the patients were clinically diagnosed with progressive keratoconus. Twenty (20) patients underwent SMILE surgery (first group), and twenty (20) patients underwent lenticule implantation (second group). Visual acuity, corneal topography, electron microscop,anterior segment optical coherence tomography, were analyzed.

Outcome:

Central corneal thickness were improved at the same day of surgery and vision started to improve at first week postoperatively in the second group (lenticule implant group). Corneal topography showed a statistically significant decrease in the anterior K1 and K2. All the grafts from both groups were clearly visible by anterior segment optical coherence tomography observation and electron microscope. The central corneal thickness was stable during the 6-month study period. No complications were observed during short term follow-up.

Opinion:

In our opinion, the present study may suggest that this procedure, using fresh lenticule with stromal stem cells and live keratocites is safe, reliable, and effectively increases corneal thickness and improves visual acuity with no adverse effects, which may provide new avenues in the treatment of corneal ectasia.

Key Words:

keratoconus,small incision,fresh lenticule, stromal implantation,stromal stem cells, Smile surgery

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients clinically diagnosed with progressive keratoconus

Exclusion Criteria

• Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smile Group	Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery	Twenty patients (20) underwent SMILE surgery (first group)
Lenticule Group	Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery	Twenty patients (20) underwent lenticule implantation (second group)

Primary Outcome Measures

Name	Time	Method
Increase of corneal thickness at patients Lenticule group	12 months	Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes

Secondary Outcome Measures

Name	Time	Method
Improvement of visual acuity at patients Lenticule group	12 months	Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo