Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery.
- Who it may be relevant to
- Registry conditions: Keratoconus. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kosovo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- 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
Primary outcome measures
- Increase of corneal thickness at patients Lenticule group [Time frame: 12 months]
Secondary outcome measures (1)
- Improvement of visual acuity at patients Lenticule group [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Kosovo · 1 center
- Eye Hospital Pristina — Pristina
Identifiers
NCT: NCT04591587 · EyeHPristina