KeratoconusNCT04591587
Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
A study testing Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery in people with Keratoconus, run by Dr. Faruk Semiz at 1 site in Kosovo.
Trial summary
CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Jan 2018to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients clinically diagnosed with progressive keratoconus
Who cannot join
- Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
CORNEAL LENTICULE IMPLANTATION IN KERATOCONUS DISEASE WITH RELEX SMILE SURGERY
Read the 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
- Conditions
- Keratoconus
- Being tested
- Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery
- Keywords
- Keratoconus, Small Incision, Fresh Lenticule, Stromal Implantation, Stromal Stem Cells, Smile Surgery
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenticule Implantation in Keratoconus Disease with RELEX Smile SurgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Smile Group | Active comparator | Twenty patients (20) underwent SMILE surgery (first group) Receives: Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery |
| Lenticule Group | Active comparator | Twenty patients (20) underwent lenticule implantation (second group) Receives: Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of corneal thickness at patients Lenticule group
Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes
Measured: 12 months
Secondary outcomes (1)
Improvement of visual acuity at patients Lenticule group
Increase of visual acuity using fresh lenticule, decrease of astigmatism and increase of corneal thickness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Both models participated in this study. Model ages were from 20 up to 45
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Faruk Semiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591587
- Sponsor's protocol ID
- EyeHPristina
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Lenticule Implantation in Keratoconus Disease With Relex Smile Surgery
- ClinicalTrials.gov ID
- NCT04591587
- Acronym / sponsor ID
- EyeHPristina
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Small Incision, Fresh Lenticule, Stromal Implantation, Stromal Stem Cells, Smile Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Faruk SemizUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both models participated in this study. Model ages were from 20 up to 45
| Arm | Type | Receives |
|---|---|---|
| Smile Group | Active comparator | Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile SurgeryTwenty patients (20) underwent SMILE surgery (first group) |
| Lenticule Group | Active comparator | Procedure: Lenticule Implantation in Keratoconus Disease with RELEX Smile SurgeryTwenty patients (20) underwent lenticule implantation (second group) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients clinically diagnosed with progressive keratoconus
Key exclusion criteria (1 listed)
- Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenticule Implantation in Keratoconus Disease with RELEX Smile SurgeryLenticule 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 | Procedure or surgery | Lenticule Group, Smile Group |
Primary outcome
Increase of corneal thickness at patients Lenticule group
Time frame: 12 months
Increase of corneal central thickness using fresh lenticule with stromal stem cells and live keratocytes
1 secondary outcome
Improvement of visual acuity at patients Lenticule group
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery in people with Keratoconus, run by Dr. Faruk Semiz at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of corneal thickness at patients Lenticule group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.