KeratoconusPhase 2/3CSKNCT01743443
Corneal Sensitivity Cross-linking Keratoconus
A Phase 2/3 study testing Cochet-Bonnet esthesiometer central corneal sensitivity in people with Keratoconus, run by Instituto de Olhos de Goiania at 1 site in Brazil.
Trial summary
To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Cochet-Bonnet esthesiometer central corneal sensitivity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Oct 2012
- Phase
- Phase 2/3
- 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 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be at least 18 years of age
- Provide written consent and sign a HIPAA form
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- For females capable of becoming pregnant,agreet o have uurine pregnancy testing performed prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment and continue to use the method until 1 month after the last dose of investigational product.
- Having topographic evidence of keratoconus which is graded as lower stage progressive keratoconus
- Presence of central or inferior steepening on the Pentacam map
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- Steepest keratometry (Kmax) value greater than or equal to 51.00D
- BSCVA of 80 letters or fewer for keratoconus on ETDRS chart
- Contact lens wearers only: remove contact lenses one week prior to the screening refraction
- Contact lens wearers only: manifest refraction must be stable between two visits that occur at least 7 days apart
Who cannot join
- Contraindications, sensitivity or known allergy to the use of the test articles(S) or their components
- If female, be pregnant, nursing, or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study
- Eyes classified as either normal,atypical normal,keratoconus suspect or mild keratoconus on the severity grading scheme
- A history of the insertion of INTACS in the eye to be treated
- A history of previous limbal relaxing incision procedure in the eye to be treated
- Corneal pachymetry that is <350 microns at the thinnest point measured by Pentacam in the eye to be treated
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- Eyes which are aphakic
- Eyes which are pseudophakic and do not have a UV blocking lens implanted
- Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
- A history of delayed epithelial healing in the eye to be treated
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
- Patients with a currnet condition that, in the investigator's opinion,would interfere with or prolong epithelial healing
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the crosslinking treatment
- A history of previous corneal crosslinking treatment in the eye to be treated
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corneal Sensitivity Changes Following Cross-linking for Progressive Lower Stage Keratoconus
To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus.
Read the detailed description
Thirty eight eyes of 19 patients (11 women, 8 men) were included in a prospective, nonrandomized clinical study. Mean patient age was 22 years (range, 18-26 years). Inclusion criteria were low stage bilateral progressive keratoconus, transparent cornea and thinnest corneal thickness ≥ 440 µm. Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.
- Conditions
- Keratoconus
- Being tested
- Cochet-Bonnet esthesiometer central corneal sensitivity
- Keywords
- Corneal sensitivity, Cross-linking, Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochet-Bonnet esthesiometer central corneal sensitivityOther
Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.
| Study group | Role | What they receive |
|---|---|---|
| Sensitiviy | Experimental | Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm. Receives: Other: Cochet-Bonnet esthesiometer central corneal sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal sensitivity
To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus.
Measured: Central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. The avarage was 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMar 2009
- Primary completionOct 2012
- Study completionOct 2012
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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joao Nassaralla, Instituto de Olhos de Goiania
- Investigators
- Belquiz A Nassaralla, MD PhD, Study chair, Instituto de Olhos de Goiania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743443
- Sponsor's protocol ID
- ARVO - BN - 2013
- Acronym
- CSK
- Status last verified
- Dec 2012
- First submitted
- 1 Dec 2012
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Sensitivity Changes Following Cross-linking for Progressive Lower Stage Keratoconus
- ClinicalTrials.gov ID
- NCT01743443
- Acronym / sponsor ID
- CSK / ARVO - BN - 2013
- Conditions
- Keratoconus
- Keywords
- Corneal sensitivity, Cross-linking, Keratoconus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Dec 2012 (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.
To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus.
Detailed description
Thirty eight eyes of 19 patients (11 women, 8 men) were included in a prospective, nonrandomized clinical study. Mean patient age was 22 years (range, 18-26 years). Inclusion criteria were low stage bilateral progressive keratoconus, transparent cornea and thinnest corneal thickness ≥ 440 µm. Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensitiviy | Experimental | Other: Cochet-Bonnet esthesiometer central corneal sensitivityUsing the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Be at least 18 years of age
- Provide written consent and sign a HIPAA form
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- For females capable of becoming pregnant,agreet o have uurine pregnancy testing performed prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment and continue to use the method until 1 month after the last dose of investigational product.
- Having topographic evidence of keratoconus which is graded as lower stage progressive keratoconus
Key exclusion criteria (15 listed)
- Contraindications, sensitivity or known allergy to the use of the test articles(S) or their components
- If female, be pregnant, nursing, or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study
- Eyes classified as either normal,atypical normal,keratoconus suspect or mild keratoconus on the severity grading scheme
- A history of the insertion of INTACS in the eye to be treated
- A history of previous limbal relaxing incision procedure in the eye to be treated
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 |
|---|---|---|
| Cochet-Bonnet esthesiometer central corneal sensitivityUsing the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm. | Other | Sensitiviy |
Primary outcome
Corneal sensitivity
Time frame: Central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. The avarage was 12 weeks
To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus.
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 6 Dec 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.
Belquiz A Nassaralla, MD PhD study chair
Instituto de Olhos de Goiania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cochet-Bonnet esthesiometer central corneal sensitivity in people with Keratoconus, run by Instituto de Olhos de Goiania at 1 site in Brazil.
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 10 inclusion and 15 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 6 Dec 2012. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Corneal sensitivity (time frame: Central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. The avarage was 12 weeks). 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 6 Dec 2012.