Progressive KeratoconusNCT01411384
Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus
A study testing Corneal collagen cross-linking and Ocular Response Analyzer (ORA) in people with Progressive Keratoconus, run by Democritus University of Thrace.
Trial summary
This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF) in a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL). Furthermore, among the objectives of the study is to reveal correlations between CH and CRF and a series of corneal indexes like the Corneal… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- Corneal collagen cross-linking and Ocular Response Analyzer (ORA)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2010
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Progressive keratoconus in consecutive corneal topographies
- Changes in refractive power
- Deterioration of the visual acuity within a period of two years
Who cannot join
- Glaucoma
- Glaucoma suspicion
- Intraocular pressure lowering drugs administration
- Central Corneal Thickness less than 400μm
- K-readings more than 60D
- History of herpetic keratitis
Show all 12Show fewer
- Corneal scarring
- Severe eye dryness
- Pregnancy
- Nursing
- Current corneal infection
- Underlying autoimmune disease
About this study
This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF) in a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL). Furthermore, among the objectives of the study is to reveal correlations between CH and CRF and a series of corneal indexes like the Corneal Thickness (CT), mean keratometry (Km) and corneal astigmatism (Astig).
The study adhered to the tenets of the Declaration of Helsinki and written informed consent was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ), in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing primarily on the conditions of the anterior segment of the eye.
Read more
Participants were recruited from the Outpatients Cornea service of the EIT in a consecutive if eligible basis. Fifty (50) eyes of thirty (30) patients with keratoconus were recruited for the sake of the study and formed the keratoconus group (KG). Eligible subjects for the keratoconus group had to present progressive keratoconus in consecutive corneal topographies, changes in refractive power, and deterioration of the visual acuity within a period of two years. Exclusion criteria included glaucoma, glaucoma suspicion, and intraocular pressure (IOP) lowering drugs administration. Further to glaucoma, exclusion criteria included central corneal thickness (CCT) less than 400μm, K-readings more than 60D, a history of herpetic keratitis, corneal scarring, severe eye dryness, pregnancy or nursing, current corneal infection, or underlying autoimmune disease.
Fifty (50) eyes of fifty (50) non-keratoconic, age-matched, individuals who visited our outpatient service formed the control group (CG). Further to keratoconus, and a spherical equivalent error above 3D, the same exclusion criteria applied to the control group members, as well. All participants wearing contact lenses were instructed to discontinue contact lens wear at least a month before measurements.
CRF and CH parameters were obtained while the patient was sitting on a chair in front of the Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device. Upon successful fixation of the patient's eye on a red blinking target, the operator activated the device. An air puff was released by a non-contact probe, which scanned the central area of the eye and sent a signal to the ORA. In brief, the air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of CH which is related to the viscoelastic structure of the corneal tissue, and is calculated as the difference between the two pressure values at the two applanation processes, and CRF which is indicative of the overall resistance of the cornea and is calculated as a linear function of the two pressures associated with the two applanation. In order to ensure accurate results, ORA was done four times for each eye, by the same operator. Signals that differ significantly in appearance from the other signals from the same eye were deleted.
The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. The ultraviolet A (UVA) radiation source that was used is UV-XTM (IROC AG, Zurich, Switzerland). In details, an 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well, in order to sustain the necessary concentration of the riboflavin. Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.
After treatment all patients were prescribed topical ofloxacin drops qid, fluorometholone qid and diclofenac nitrate qid, accompanied by frequent instillation of artificial tears. Soft therapeutic lens was applied until complete re-epithelialization of the cornea was detected. Follow up visits were performed on the 1st day, 7th day, 1st, 3rd, 6th and 12th month after the operation.
- Conditions
- Progressive Keratoconus
- Being tested
- Corneal collagen cross-linking, Ocular Response Analyzer (ORA)
- Keywords
- Keratoconus (KC), Corneal collagen cross-linking (CXL), Corneal hysteresis (CH), Corneal resistance factor (CRF), Ocular Response Analyzer (ORA)
- 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 cross-linkingProcedure or surgery
The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. An 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation. Balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.
Ocular Response Analyzer (ORA)Device
An air puff is released by a non-contact probe, which scanned the central area of the eye and send a signal to the ORA device. The air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of Corneal Hysteresis and Corneal Resistance Factor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Corneal Hysteresis (CH)
Measured: at 3rd, 6th and 12th month postoperatively
Change from baseline in Corneal Resistance Factor (CRF)
Measured: at 3rd, 6th and 12th month postoperatively
Secondary outcomes (3)
Change from baseline in Average keratometry (Km)
Measured: at 3rd, 6th and 12th month postoperatively
Change from baseline in Corneal Thickness (CT)
Measured: at 3rd, 6th and 12th month postoperatively
Change from baseline in Corneal Astigmatism (Astig.)
Measured: at 3rd, 6th and 12th month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2010
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.
- 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
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Investigators
- Georgios Labiris, MD, PhD, Principal investigator, Democritus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411384
- Sponsor's protocol ID
- 20/21-07-2011
- Status last verified
- Jul 2011
- First submitted
- 1 Aug 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus
- ClinicalTrials.gov ID
- NCT01411384
- Acronym / sponsor ID
- 20/21-07-2011
- Conditions
- Progressive Keratoconus
- Keywords
- Keratoconus (KC), Corneal collagen cross-linking (CXL), Corneal hysteresis (CH), Corneal resistance factor (CRF), Ocular Response Analyzer (ORA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Aug 2011 (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.
This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF) in a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL). Furthermore, among the objectives of the study is to reveal correlations between CH and CRF and a series of corneal indexes like the Corneal Thickness (CT), mean keratometry (Km) and corneal astigmatism (Astig).
The study adhered to the tenets of the Declaration of Helsinki and written informed consent was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ), in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing primarily on the conditions of the anterior segment of the eye.
Participants were recruited from the Outpatients Cornea service of the EIT in a consecutive if eligible basis. Fifty (50) eyes of thirty (30) patients with keratoconus were recruited for the sake of the study and formed the keratoconus group (KG). Eligible subjects for the keratoconus group had to present progressive keratoconus in consecutive corneal topographies, changes in refractive power, and deterioration of the visual acuity within a period of two years. Exclusion criteria included glaucoma, glaucoma suspicion, and intraocular pressure (IOP) lowering drugs administration. Further to glaucoma, exclusion criteria included central corneal thickness (CCT) less than 400μm, K-readings more than 60D, a history of herpetic keratitis, corneal scarring, severe eye dryness, pregnancy or nursing, current corneal infection, or underlying autoimmune disease.
Fifty (50) eyes of fifty (50) non-keratoconic, age-matched, individuals who visited our outpatient service formed the control group (CG). Further to keratoconus, and a spherical equivalent error above 3D, the same exclusion criteria applied to the control group members, as well. All participants wearing contact lenses were instructed to discontinue contact lens wear at least a month before measurements.
CRF and CH parameters were obtained while the patient was sitting on a chair in front of the Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device. Upon successful fixation of the patient's eye on a red blinking target, the operator activated the device. An air puff was released by a non-contact probe, which scanned the central area of the eye and sent a signal to the ORA. In brief, the air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of CH which is related to the viscoelastic structure of the corneal tissue, and is calculated as the difference between the two pressure values at the two applanation processes, and CRF which is indicative of the overall resistance of the cornea and is calculated as a linear function of the two pressures associated with the two applanation. In order to ensure accurate results, ORA was done four times for each eye, by the same operator. Signals that differ significantly in appearance from the other signals from the same eye were deleted.
The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. The ultraviolet A (UVA) radiation source that was used is UV-XTM (IROC AG, Zurich, Switzerland). In details, an 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well, in order to sustain the necessary concentration of the riboflavin. Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.
After treatment all patients were prescribed topical ofloxacin drops qid, fluorometholone qid and diclofenac nitrate qid, accompanied by frequent instillation of artificial tears. Soft therapeutic lens was applied until complete re-epithelialization of the cornea was detected. Follow up visits were performed on the 1st day, 7th day, 1st, 3rd, 6th and 12th month after the operation.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Progressive keratoconus in consecutive corneal topographies
- Changes in refractive power
- Deterioration of the visual acuity within a period of two years
Key exclusion criteria (12 listed)
- Glaucoma
- Glaucoma suspicion
- Intraocular pressure lowering drugs administration
- Central Corneal Thickness 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 collagen cross-linkingThe same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. An 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation. Balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea. | Procedure or surgery | – |
| Ocular Response Analyzer (ORA)An air puff is released by a non-contact probe, which scanned the central area of the eye and send a signal to the ORA device. The air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of Corneal Hysteresis and Corneal Resistance Factor. | Device | – |
Primary outcome
Change from baseline in Corneal Hysteresis (CH)
Time frame: at 3rd, 6th and 12th month postoperatively
Change from baseline in Corneal Resistance Factor (CRF)
Time frame: at 3rd, 6th and 12th month postoperatively
3 secondary outcomes
Change from baseline in Average keratometry (Km)
Time frame: at 3rd, 6th and 12th month postoperatively
Change from baseline in Corneal Thickness (CT)
Time frame: at 3rd, 6th and 12th month postoperatively
Change from baseline in Corneal Astigmatism (Astig.)
Time frame: at 3rd, 6th and 12th month postoperatively
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 22 Feb 2012.
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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.
Georgios Labiris, MD, PhD principal investigator
Democritus University
Questions about this trial
What is this clinical trial studying?
A study testing Corneal collagen cross-linking and Ocular Response Analyzer (ORA) in people with Progressive 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 3 inclusion and 12 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 22 Feb 2012. 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?
Change from baseline in Corneal Hysteresis (CH) (time frame: at 3rd, 6th and 12th month postoperatively). The study lists 2 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 22 Feb 2012.