Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery

Dr. Faruk Semiz

Status: Invitation-only

Conditions: Keratoconus

Treatments: Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04591587

EyeHPristina

Details and patient eligibility

About

CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Smile Group

Active Comparator group

Description:

Twenty patients (20) underwent SMILE surgery (first group)

Treatment:

Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery

Lenticule Group

Active Comparator group

Description:

Twenty patients (20) underwent lenticule implantation (second group)

Treatment:

Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery