KeratoconusNCT01845714
Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
A study testing Corneal Cross Linking and Corneal Cross Linking combined with topoguided PRK in people with Keratoconus, run by Democritus University of Thrace.
Trial summary
Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal Cross Linking and Corneal Cross Linking combined with topoguided PRK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2012
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus
- present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.
- Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:
- an increase of 1.00 diopter (D) or more in the steepest keratometry measurement
- an increase of 1.00 D or more in manifest cylinder
- an increase of 0.50 D or more in manifest refraction spherical equivalent.
Who cannot join
- glaucoma
- suspicion for glaucoma
- IOP-lowering medications
- central corneal thickness (CCT) less than 400μm
- K-readings more than 60D
- history of herpetic keratitis
Show all 11Show fewer
- corneal scarring
- severe eye dryness
- pregnancy or nursing
- current corneal infection
- or underlying autoimmune disease KG members were further sub-divided into CxL and tCxL groups, according to their eligibility for treatment with CxL or CxL with tPRK. In order to be eligible for tCxL, group participants should, additionally, have CCT above 450μm.
About this study
Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.
- Conditions
- Keratoconus
- Being tested
- Corneal Cross Linking, Corneal Cross Linking combined with topoguided PRK
- Keywords
- Keratoconus, Corneal cross Linking, Topo guided PRK, Quality of Life
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Cross LinkingProcedure or surgery
Corneal Cross Linking combined with topoguided PRKProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cross Linking Group (CxL group) | Active comparator | Patients that received CXL Receives: Procedure: Corneal Cross Linking |
| Cross Linking with topo-guided PRK (tCxL) | Active comparator | Patients that received tCxL Receives: Procedure: Corneal Cross Linking combined with topoguided PRK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision Specific quality of Life (VS-QoL)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionOct 2012
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845714
- Sponsor's protocol ID
- EIT-KC-VSQOL3
- Status last verified
- Jan 2017
- First submitted
- 30 Apr 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
Publications
Labiris G, Giarmoukakis A, Sideroudi H, Kozobolis V. Impact of keratoconus, cross-linking and cross-linking combined with topography-guided photorefractive keratectomy on self-reported quality of life: a 3-year update. Cornea. 2013 Sep;32(9):e186-8. doi: 10.1097/ICO.0b013e318296e13c. No abstract available.
PubMed 23807006
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
- ClinicalTrials.gov ID
- NCT01845714
- Acronym / sponsor ID
- EIT-KC-VSQOL3
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Corneal cross Linking, Topo guided PRK, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 May 2013 (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.
Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross Linking Group (CxL group) | Active comparator | Procedure: Corneal Cross LinkingPatients that received CXL |
| Cross Linking with topo-guided PRK (tCxL) | Active comparator | Procedure: Corneal Cross Linking combined with topoguided PRKPatients that received tCxL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus
- present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.
- Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:
- an increase of 1.00 diopter (D) or more in the steepest keratometry measurement
- an increase of 1.00 D or more in manifest cylinder
Key exclusion criteria (11 listed)
- glaucoma
- suspicion for glaucoma
- IOP-lowering medications
- central corneal thickness (CCT) less than 400μm
- K-readings more than 60D
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 Cross Linking | Procedure or surgery | Cross Linking Group (CxL group) |
| Corneal Cross Linking combined with topoguided PRK | Procedure or surgery | Cross Linking with topo-guided PRK (tCxL) |
Primary outcome
Vision Specific quality of Life (VS-QoL)
Time frame: 3 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 18 Jan 2017.
- Results publication: PubMed 23807006Labiris G, Giarmoukakis A, Sideroudi H, Kozobolis V. Impact of keratoconus, cross-linking and cross-linking combined with topography-guided photorefractive keratectomy on self-reported quality of life: a 3-year update. Cornea. 2013 Sep;32(9):e186-8. doi: 10.1097/ICO.0b013e318296e13c. No abstract available.
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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 Corneal Cross Linking and Corneal Cross Linking combined with topoguided PRK in people with Keratoconus, run by Democritus University of Thrace.
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 6 inclusion and 11 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 18 Jan 2017. 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?
Vision Specific quality of Life (VS-QoL) (time frame: 3 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 NCT01845714, 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 18 Jan 2017.