KeratoconusNCT02301598
Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
A study testing FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty) in people with Keratoconus and Corneal Opacity, run by The S.N. Fyodorov Eye Microsurgery State Institution.
Trial summary
The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities Read more about this study
- Who is it for?
- Ages 18 to 52 years
- Conditions the study is for
- Keratoconus, Corneal Opacity
- What is being tested?
- FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 52 years
- No healthy volunteers
- Adult
Who may be able to join
- Advanced keratoconus or stromal corneal scattering
- Normal endothelial cell density
Who cannot join
- Acute keratoconus in the anamnesis
- Low endothelial cell density
- Age under 18 years
About this study
The purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities
Read the detailed description
Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability.
Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed.
All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.
- Conditions
- Keratoconus, Corneal Opacity
- Being tested
- FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)
- Keywords
- femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy
- Medical subject headings
- Keratoconus, Corneal Opacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)Procedure or surgery
Also called Femto-ALK
The procedure was a non-penetrating transplantation of 80% thickness corneal graft
| Study group | Role | What they receive |
|---|---|---|
| FS-ALK | Experimental | Femtosecond laser-assisted maximum thickness anterior lamellar keratoplasty (FS-ALK) was performed for 11 eyes of 11 patients with advanced keratoconus and 2 eyes of 2 patients with superficial corneal scattering. Receives: Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean endothelial cell loss
Measured: 12 months after surgery
Mean postoperative astigmatism
Measured: 12 months after surgery
UCVA (uncorrected visual acuity)
Measured: 12 months after surgery
BSCVA (best spectacle-corrected visual acuity)
Measured: 12 months after surgery
Secondary outcomes (4)
Corneal hysteresis
Evaluation of biomechanical qualities of the cornea
Measured: 12 months after surgery
Corneal resistance factor
Evaluation of biomechanical qualities of the cornea
Measured: 12 months after surgery
Central corneal thickness
measured by OCT (optical coherence tomography - Optovue)
Measured: 12 months after surgery
Residual recipient's tissue thickness
measured by OCT (optical coherence tomography - Optovue)
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alexey Pashtaev, The S.N. Fyodorov Eye Microsurgery State Institution
- Investigators
- Boris Malyugin, MD,PhD,prof., Study director, The S.N. Fedorof Federal State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301598
- Sponsor's protocol ID
- FS-1
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Laser-assisted Anterior Lamellar Keratoplasty
- ClinicalTrials.gov ID
- NCT02301598
- Acronym / sponsor ID
- FS-1
- Conditions
- Keratoconus, Corneal Opacity
- Keywords
- femtosecond laser, anterior lamellar keratoplasty, atomic-force microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Nov 2014 (estimated)
- 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 purpose of the study is evaluating safety and clinical efficiency of full femtosecond laser-assisted anterior lamellar keratoplasty (FS-ALK) for curing patients with keratoconus and corneal opacities
Detailed description
Keratoplasty is the most widely spread tissue transplantation procedure. Although penetrating keratoplasty (PKP) is still commonly used for curing corneal dystrophy and opacities of different genesis, lamellar techniques provide significant advantages in terms of safety and predictability.
Al in all 13 FS-ALK procedures were performed for 11 eyes with advanced keratoconus and 2 eyes with superficial corneal scattering Before and after surgery uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), postoperative astigmatism, endothelial cell loss, central cornea thickness, residual recipient's tissue thickness, corneal hysteresis (CH) and corneal resistance factor (CFR) were evaluated . At 1-year follow-up Confoscan investigation of donor-recipient interface was performed.
All FS-ALK procedures were performed with Intralase FS 60kHz femtosecond laser in a following way. At first a 80% thickness corneal graft was prepared. Then maximum thickness recipients corneal dissection was performed according to OCT (optical coherence tomography) data and superficial tissue was removed. Transplant was fixed in a resulted bed by continuous suture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FS-ALK | Experimental | Procedure: FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)Femtosecond laser-assisted maximum thickness anterior lamellar keratoplasty (FS-ALK) was performed for 11 eyes of 11 patients with advanced keratoconus and 2 eyes of 2 patients with superficial corneal scattering. |
Who may qualify
- Ages
- 18 to 52 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Advanced keratoconus or stromal corneal scattering
- Normal endothelial cell density
Key exclusion criteria (3 listed)
- Acute keratoconus in the anamnesis
- Low endothelial cell density
- Age under 18 years
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 |
|---|---|---|
| FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)Also: Femto-ALKThe procedure was a non-penetrating transplantation of 80% thickness corneal graft | Procedure or surgery | FS-ALK |
Primary outcome
Mean endothelial cell loss
Time frame: 12 months after surgery
Mean postoperative astigmatism
Time frame: 12 months after surgery
UCVA (uncorrected visual acuity)
Time frame: 12 months after surgery
BSCVA (best spectacle-corrected visual acuity)
Time frame: 12 months after surgery
4 secondary outcomes
Corneal hysteresis
Time frame: 12 months after surgery
Corneal resistance factor
Time frame: 12 months after surgery
Central corneal thickness
Time frame: 12 months after surgery
Residual recipient's tissue thickness
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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. This study is not recruiting at the moment.
Boris Malyugin, MD,PhD,prof. study director
The S.N. Fedorof Federal State Institution
Questions about this trial
What is this clinical trial studying?
A study testing FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty) in people with Keratoconus and Corneal Opacity, run by The S.N. Fyodorov Eye Microsurgery State Institution.
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 2 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: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean endothelial cell loss (time frame: 12 months after surgery). The study lists 4 primary outcomes in all. 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 2 Dec 2014.