Progressive KeratoconusNCT02721628
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
A study testing Epi-keratoplasty, Collagen Cross-Linking and Femtosecond laser in people with Progressive Keratoconus, run by Sun Yat-sen University at 1 site in China.
Trial summary
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- Epi-keratoplasty, Collagen Cross-Linking and Femtosecond laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Mar 2018
- 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
- diagnosis of Keratoconus
- Age ≥ 18 years old
- Corneal thickness ≥ 400 µm
- Progressive stage 1 to 3 keratoconus (Krumeich classification)
Who cannot join
- Corneal thickness < 400µm
- Concomitant corneal disease
- History of corneal surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ZhongShan Ophthalmic Center
Guangzhou, Guangdong, 510060
Gao Xinbo, MD, ice.freeport@163.com
Gao Xinbo, MD
About this study
Official title: Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
Read the detailed description
Keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities.
Collagen Cross-Linking (CXL) is widely used in progressive keratoconus. The cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-A radiation. The performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. However, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring.
Epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. The procedure was assisted by femtosecond laser which allows precisely and neatly cutting. The graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.
- Conditions
- Progressive Keratoconus
- Being tested
- Epi-keratoplasty, Collagen Cross-Linking, Femtosecond laser
- Keywords
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epi-keratoplastyProcedure or surgery
Femtosecond laser assisted Epi-keratoplasty
Collagen Cross-LinkingProcedure or surgery
Also called CCL
Collagen Cross-Linking: Standard procedure, which is descriptor bellows: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes
Femtosecond laserDevice
Use in the epic-keratoplasty surgery
| Study group | Role | What they receive |
|---|---|---|
| Epi-keratoplasty Group | Experimental | Epi-keratoplasty Group: Reversible keratoplasty performed with only the removal of corneal epithelium of the host cornea. A donor graft is transplanted on the recipients' eye locating on the Bowman's layer. Receives: Procedure: Epi-keratoplasty; Device: Femtosecond laser |
| Collagen Cross-Linking Group | Active comparator | Collagen Cross-Linking: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes Receives: Procedure: Collagen Cross-Linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Spherical equivalent
Measured: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Secondary outcomes (3)
maximum keratometry (K-max) derived from computerized video keratography
Measured: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
minimum keratometry
also from computerized video keratography, the opposite description of K-max
Measured: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Visual acuity
Measured: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 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 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive KeratoconusStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Xinbo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721628
- Sponsor's protocol ID
- zoc-ekccl2015
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2016
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Laser Assisted Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT02721628
- Acronym / sponsor ID
- zoc-ekccl2015
- Conditions
- Progressive Keratoconus
- Keywords
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 29 Mar 2016 (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.
Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus
Detailed description
Keratoconus is a bilateral corneal ecstatic disease which is not uncommon and always behaves progressively and results in visual impairment by inducing irregular astigmatism and corneal opacities.
Collagen Cross-Linking (CXL) is widely used in progressive keratoconus. The cornea is soaked with a riboflavin solution and then being exposed to ultraviolet-A radiation. The performance creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. However, the effectiveness is not satisfied and accompanied with risks of side effects and serious complications, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, infection and stromal opacity due to corneal scarring.
Epi-keratoplasty is a reversible technique in which a corneal graft is transplanted on the recipients' eye with only removal of the epithelium of the receptor cornea. The procedure was assisted by femtosecond laser which allows precisely and neatly cutting. The graft strengths the whole host corneal rigidity and roughness and therefore renders the progression of keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epi-keratoplasty Group | Experimental | Procedure: Epi-keratoplasty, Device: Femtosecond laserEpi-keratoplasty Group: Reversible keratoplasty performed with only the removal of corneal epithelium of the host cornea. A donor graft is transplanted on the recipients' eye locating on the Bowman's layer. |
| Collagen Cross-Linking Group | Active comparator | Procedure: Collagen Cross-LinkingCollagen Cross-Linking: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of Keratoconus
- Age ≥ 18 years old
- Corneal thickness ≥ 400 µm
- Progressive stage 1 to 3 keratoconus (Krumeich classification)
Key exclusion criteria (3 listed)
- Corneal thickness < 400µm
- Concomitant corneal disease
- History of corneal 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 |
|---|---|---|
| Epi-keratoplastyFemtosecond laser assisted Epi-keratoplasty | Procedure or surgery | Epi-keratoplasty Group |
| Collagen Cross-LinkingAlso: CCLCollagen Cross-Linking: Standard procedure, which is descriptor bellows: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes | Procedure or surgery | Collagen Cross-Linking Group |
| Femtosecond laserUse in the epic-keratoplasty surgery | Device | Epi-keratoplasty Group |
Primary outcome
Changes of Spherical equivalent
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
3 secondary outcomes
maximum keratometry (K-max) derived from computerized video keratography
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
minimum keratometry
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Visual acuity
Time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Progressive Keratoconus
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
Enrolling by invitationPhase 1/2
Study of TN-001 Topical Eyedrops for Keratoconus
Keratoconus
RecruitingPhase 3
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Progressive Keratoconus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epi-keratoplasty, Collagen Cross-Linking and Femtosecond laser in people with Progressive Keratoconus, run by Sun Yat-sen University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinbo Gao, MD, PHD (+8613570942794, ice.freeport@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Spherical equivalent (time frame: 01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years). 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 Mar 2016.