Clinical trial NCT04591587: Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
Official title: Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
Small Incision
Fresh Lenticule
Stromal Implantation
Stromal Stem Cells
Smile Surgery
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Both models participated in this study. Model ages were from 20 up to 45
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Increase of corneal thickness at patients Lenticule group
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of visual acuity at patients Lenticule group
timeFrame: 12 months
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References: