KeratoconusNCT02590549
MyoRing Implantation With Corneal Collagen Crosslinking for Keratoconus
A study testing Corneal Collagen Crosslinking and Ufalink in people with Keratoconus, run by Ufa Eye Research Institute.
Trial summary
A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal Collagen Crosslinking and Ufalink
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- a diagnosis of keratoconus, intolerance for contact lenses or glasses
- a documented progression of disease. This progression was defined by the following changes over 1 year: an increase of the steepest K by 1.0 diopter (D) or more in manifest cylinder, or an increase of 0.5 D or more in manifest spherical equivalent (SE) refraction by repeated keratotopography ODP-scan ARK-1000 (Nidek, Japan)
Who cannot join
- minimal pachymetry of less than 380 μm,
- a history of previous ocular pathology or ocular surgery;
- pregnancy or breastfeeding;
- corneal scarring.
About this study
Official title: Complete Corneal Ring (MyoRing) Implantation Combined With Corneal Collagen Crosslinking for Keratoconus
A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in 2003, has become a standard treatment for progressive keratoconus to slow or possibly stop progression of disease.
The formation of the stromal pocket during MyoRing implantation offers the opportunity for simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to provide combined treatment in patients with progressive keratoconus.
- Conditions
- Keratoconus
- Being tested
- Corneal Collagen Crosslinking, Ufalink
- Keywords
- Keratoconus, riboflavin, corneal collagen crosslinking, intrasromal ring
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Collagen CrosslinkingProcedure or surgery
Sterile riboflavin solution 0.1% was then continuously injected for 3 minutes into the corneal pocket via a standard 0.3-mm cannula through the incision tunnel.
Standard surface UVA irradiation (370 nm, 3 mW/cm2) was then applied at a 5-cm distance for 30 minutes.
After UVA irradiation, a flexible MyoRing intracorneal implant was inserted into the corneal pocket,
UfalinkDevice
UVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation
| Study group | Role | What they receive |
|---|---|---|
| MyoRing Implantation combined with corneal cross linking | Experimental | Surgical technique: Implantation of a MyoRing in a corneal pocket was performed by using a PocketMaker microkeratome a guided, vibrating diamond blade to create a stromal pocket 9 mm in diameter at a 300-μm depth via a 4- to 5-mm-wide corneal tunnel followed by Corneal Collagen Crosslinking (standard surface UVA irradiation (370 nm, 3 mW/cm2) using Ufalink device) Receives: Procedure: Corneal Collagen Crosslinking; Device: Ufalink |
What is being measured
The primary outcome is the main question the study is designed to answer.
K max
Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value
Measured: 2 years
Secondary outcomes (1)
Visual acuity as assessed by Decimal system
Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufa Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mukharram Bikbov, Professor, Study chair, Ufa Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590549
- Sponsor's protocol ID
- Myoring_CXL
- Status last verified
- Oct 2015
- First submitted
- 25 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
Publications
Jadidi K, Mosavi SA, Nejat F, Naderi M, Janani L, Serahati S. Intrastromal corneal ring segment implantation (keraring 355 degrees ) in patients with central keratoconus: 6-month follow-up. J Ophthalmol. 2015;2015:916385. doi: 10.1155/2015/916385. Epub 2015 Jan 5.
PubMed 25685395
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Corneal Ring (MyoRing) Implantation Combined With Corneal Collagen Crosslinking for Keratoconus
- ClinicalTrials.gov ID
- NCT02590549
- Acronym / sponsor ID
- Myoring_CXL
- Conditions
- Keratoconus
- Keywords
- Keratoconus, riboflavin, corneal collagen crosslinking, intrasromal ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ufa Eye Research InstituteUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2015 (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.
A complete intrastromal ring, MyoRing (Dioptex, GmbH, Linz, Austria), suggested by Albert Daxer in 2007, is a relatively new technique that has been demonstrated to treat keratoconus safely and effectively.Corneal collagen crosslinking (CXL), introduced by Wollensak et al. in 2003, has become a standard treatment for progressive keratoconus to slow or possibly stop progression of disease.
The formation of the stromal pocket during MyoRing implantation offers the opportunity for simultaneous introduction of riboflavin 0.1% into the pocket followed by UVA irradiation to provide combined treatment in patients with progressive keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoRing Implantation combined with corneal cross linking | Experimental | Procedure: Corneal Collagen Crosslinking, Device: UfalinkSurgical technique: Implantation of a MyoRing in a corneal pocket was performed by using a PocketMaker microkeratome a guided, vibrating diamond blade to create a stromal pocket 9 mm in diameter at a 300-μm depth via a 4- to 5-mm-wide corneal tunnel followed by Corneal Collagen Crosslinking (standard surface UVA irradiation (370 nm, 3 mW/cm2) using Ufalink device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- a diagnosis of keratoconus, intolerance for contact lenses or glasses
- a documented progression of disease. This progression was defined by the following changes over 1 year: an increase of the steepest K by 1.0 diopter (D) or more in manifest cylinder, or an increase of 0.5 D or more in manifest spherical equivalent (SE) refraction by repeated keratotopography ODP-scan ARK-1000 (Nidek, Japan)
Key exclusion criteria (4 listed)
- minimal pachymetry of less than 380 μm,
- a history of previous ocular pathology or ocular surgery;
- pregnancy or breastfeeding;
- corneal scarring.
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 |
|---|---|---|
| Corneal Collagen CrosslinkingSterile riboflavin solution 0.1% was then continuously injected for 3 minutes into the corneal pocket via a standard 0.3-mm cannula through the incision tunnel. Standard surface UVA irradiation (370 nm, 3 mW/cm2) was then applied at a 5-cm distance for 30 minutes. After UVA irradiation, a flexible MyoRing intracorneal implant was inserted into the corneal pocket, | Procedure or surgery | MyoRing Implantation combined with corneal cross linking |
| UfalinkUVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation | Device | MyoRing Implantation combined with corneal cross linking |
Primary outcome
K max
Time frame: 2 years
Using topography measurements, decrease of maximum keratometry value over the preoperative maximum keratometry value
1 secondary outcome
Visual acuity as assessed by Decimal system
Time frame: 2 years
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 29 Oct 2015.
- Background: PubMed 25685395Jadidi K, Mosavi SA, Nejat F, Naderi M, Janani L, Serahati S. Intrastromal corneal ring segment implantation (keraring 355 degrees ) in patients with central keratoconus: 6-month follow-up. J Ophthalmol. 2015;2015:916385. doi: 10.1155/2015/916385. Epub 2015 Jan 5.
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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.
Mukharram Bikbov, Professor study chair
Ufa Eye Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Collagen Crosslinking and Ufalink in people with Keratoconus, run by Ufa Eye Research Institute.
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 4 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 29 Oct 2015. 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?
K max (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590549, which also lists 1 linked publication.
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 Oct 2015.