Macular Corneal DystrophyNCT04642729
Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery
A study testing Fresh Corneal Lenticule Implantation using Relex-Smile Surgery in people with Macular Corneal Dystrophy, run by Eye Hospital Pristina Kosovo at 1 site in Kosovo.
Trial summary
The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Macular Corneal Dystrophy
- What is being tested?
- Fresh Corneal Lenticule Implantation using Relex-Smile Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Jun 2019to 1 Jun 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- indications for penetrating keratoplasty
- low transparec of corneae
- low visual acuity
Who cannot join
- active anterior segment pathology
- previous corneal or anterior segment surgery
- any infection
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
Official title: Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery
The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.
Read the detailed description
Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by bilateral cloudy regions within hazy stroma and eventually severe visual impairment.
Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in the production of keratan sulfate, which plays a role in the maintenance of corneal transparency.
According to biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.
- Conditions
- Macular Corneal Dystrophy
- Being tested
- Fresh Corneal Lenticule Implantation using Relex-Smile Surgery
- Medical subject headings
- Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Corneal Lenticule Implantation using Relex-Smile SurgeryProcedure or surgery
Also called Relex smile surgery
Knowing that the most important element is damage of stroma we used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert, for example we remove 80 µm and we insert fresh corneal lenticule 90 µm with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.
| Study group | Role | What they receive |
|---|---|---|
| ReLex Smile surgery | Other | The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser. Receives: Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery |
| fresh corneal lenticule implantation | Other | Using VisuMax Femtosecond Laser we make intrastromal pocket incision 2-3 mm in periphery of cornea (Because the macular dystrophy is in the center more progressive) and 150 µm deep to put fresh corneal lenticule. After one month using VisuMax we create a flap using autologous serum with purpose to remove more dead keratocytes and adding live keratocytes with aim to regenerate the metabolism of cornea. Receives: Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of corneal transparency
Implanting fresh corneal lenticule we add more live stem cells and keratocytes to stabilize biomechanical stability of cornea. Also making flap and putting autologous serum after one month of implanting fresh corneal lenticule we removed more dead keratocytes from macula dystrophia and added more live keratocytes which contributed to the regeneration of the cornea.
Measured: 12 months
Secondary outcomes (1)
Increase of visual acuity
After implanting fresh corneal lenticule according to clarity of cornea visual acuity increased for 2-3 m and also softening symptoms of corneal dystrophy ex. dry eyes, sensitivity to light, pain in the eye, corneal erosion etc.
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 posted24 Nov 2020
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Corneal DystrophyStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Hospital Pristina Kosovo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Faruk Semiz, Eye Hospital Pristina Kosovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642729
- Sponsor's protocol ID
- EyeHP
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex-Smile Surgery
- ClinicalTrials.gov ID
- NCT04642729
- Acronym / sponsor ID
- EyeHP
- Conditions
- Macular Corneal Dystrophy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Eye Hospital Pristina KosovoUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Nov 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.
The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.
Detailed description
Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by bilateral cloudy regions within hazy stroma and eventually severe visual impairment.
Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in the production of keratan sulfate, which plays a role in the maintenance of corneal transparency.
According to biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReLex Smile surgery | Other | Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile SurgeryThe myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser. |
| fresh corneal lenticule implantation | Other | Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile SurgeryUsing VisuMax Femtosecond Laser we make intrastromal pocket incision 2-3 mm in periphery of cornea (Because the macular dystrophy is in the center more progressive) and 150 µm deep to put fresh corneal lenticule. After one month using VisuMax we create a flap using autologous serum with purpose to remove more dead keratocytes and adding live keratocytes with aim to regenerate the metabolism of cornea. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- indications for penetrating keratoplasty
- low transparec of corneae
- low visual acuity
Key exclusion criteria (3 listed)
- active anterior segment pathology
- previous corneal or anterior segment surgery
- any infection
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 |
|---|---|---|
| Fresh Corneal Lenticule Implantation using Relex-Smile SurgeryAlso: Relex smile surgeryKnowing that the most important element is damage of stroma we used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert, for example we remove 80 µm and we insert fresh corneal lenticule 90 µm with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy. | Procedure or surgery | ReLex Smile surgery, fresh corneal lenticule implantation |
Primary outcome
Increase of corneal transparency
Time frame: 12 months
Implanting fresh corneal lenticule we add more live stem cells and keratocytes to stabilize biomechanical stability of cornea. Also making flap and putting autologous serum after one month of implanting fresh corneal lenticule we removed more dead keratocytes from macula dystrophia and added more live keratocytes which contributed to the regeneration of the cornea.
1 secondary outcome
Increase of visual acuity
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.
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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 Fresh Corneal Lenticule Implantation using Relex-Smile Surgery in people with Macular Corneal Dystrophy, run by Eye Hospital Pristina Kosovo 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 3 inclusion and 3 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 transparency (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.