Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Keratoconus Clinical Trial

Official title:

Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04591587
• Other study ID #: EyeHPristina
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: Eye Hospital Pristina Kosovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 15, 2024
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery using VisuMax Femtosecond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary objective to improve visual acuity and reduces K-values

Locations

Country	Name	City	State
Kosovo	Eye Hospital Pristina	Pristina

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Faruk Semiz

Country where clinical trial is conducted

Kosovo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of corneal thickness at patients Lenticule group	Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes	12 months
Secondary	Improvement of visual acuity at patients Lenticule group	Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness	12 months