KeratoconusNCT02189447
Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus
A study testing Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus in people with Keratoconus, run by The Eye Center and The Eye Foundation for Research in Ophthalmology.
Trial summary
Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- contact lens intolerance
- corneal thickness > 450 micrometers
- Keratometry < 56 diopters
- Astigmatism < 6 diopters
Who cannot join
- corneal thickness < 450 micrometers
- Keratometry > 56 diopters
- Astigmatism > 6 diopters
About this study
Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus
- Conditions
- Keratoconus
- Being tested
- Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus
- Keywords
- Keratoconus, Ectasia, Corneal Cross-linking
- Medical subject headings
- Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconusProcedure or surgery
Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting
| Study group | Role | What they receive |
|---|---|---|
| Refractive surgery | Experimental | Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking. Receives: Procedure: Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus
The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJan 2011
- Primary completionSep 2013
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189447
- Sponsor's protocol ID
- TEC 126
- Status last verified
- Jul 2014
- First submitted
- 5 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus
- ClinicalTrials.gov ID
- NCT02189447
- Acronym / sponsor ID
- TEC 126
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Ectasia, Corneal Cross-linking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in OphthalmologyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Jul 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.
Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refractive surgery | Experimental | Procedure: Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconusPatients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- contact lens intolerance
- corneal thickness > 450 micrometers
- Keratometry < 56 diopters
- Astigmatism < 6 diopters
Key exclusion criteria (3 listed)
- corneal thickness < 450 micrometers
- Keratometry > 56 diopters
- Astigmatism > 6 diopters
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 |
|---|---|---|
| Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconusPhotorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting | Procedure or surgery | Refractive surgery |
Primary outcome
The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus
Time frame: 6 months
The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.
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 14 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus in people with Keratoconus, run by The Eye Center and The Eye Foundation for Research in Ophthalmology.
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: finished, as of the sponsor's last update on 14 Jul 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?
The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus (time frame: 6 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 14 Jul 2014.