Progressive KeratoconusPhase 2/3CLNCT00567671
Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
A Phase 2/3 study testing Corneal collagen in people with Progressive Keratoconus and Corneal Ectasia, run by Emory University at 1 site in United States.
Trial summary
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Progressive Keratoconus, Corneal Ectasia
- What is being tested?
- Corneal collagen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2010
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus with documented progression over the previous 12 months.
- Diagnosis of corneal ectasia
- Must be able to complete all study visits
Who cannot join
- Prior corneal surgery in the keratoconus group
- Corneal scarring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.
Read the detailed description
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.
Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.
- Conditions
- Progressive Keratoconus, Corneal Ectasia
- Being tested
- Corneal collagen, Sham comparator
- Keywords
- keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
- Medical subject headings
- Keratoconus, Dilatation, Pathologic, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal collagenProcedure or surgery
Corneal collagen cross-linking with riboflavin/UVA light
Sham comparatorProcedure or surgery
Sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Corneal collagen cross-linking Receives: Procedure: Corneal collagen |
| Control | Sham comparator | Sham Treatment Receives: Procedure: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in keratometry
Measured: 3 Months
Secondary outcomes (1)
Best spectacle-corrected visual acuity
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2010
- Study completionJun 2010
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 Progressive KeratoconusStudies of the same condition, open and under way.
- More trials run by Emory 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Investigators
- R. Doyle Stulting, MD, PhD, Principal investigator, Emory Vision; Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567671
- Sponsor's protocol ID
- UVX-001
- Acronym
- CL
- Status last verified
- Jul 2009
- First submitted
- 3 Dec 2007
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hallahan KM, Rocha K, Roy AS, Randleman JB, Stulting RD, Dupps WJ Jr. Effects of corneal cross-linking on ocular response analyzer waveform-derived variables in keratoconus and postrefractive surgery ectasia. Eye Contact Lens. 2014 Nov;40(6):339-44. doi: 10.1097/ICL.0000000000000090.
PubMed 25365551
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT00567671
- Acronym / sponsor ID
- CL / UVX-001
- Conditions
- Progressive Keratoconus, Corneal Ectasia
- Keywords
- keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Dec 2007 (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.
Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.
Detailed description
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.
Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Corneal collagenCorneal collagen cross-linking |
| Control | Sham comparator | Procedure: Sham comparatorSham Treatment |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of keratoconus with documented progression over the previous 12 months.
- Diagnosis of corneal ectasia
- Must be able to complete all study visits
Key exclusion criteria (2 listed)
- Prior corneal surgery in the keratoconus group
- Corneal scarring
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 collagenCorneal collagen cross-linking with riboflavin/UVA light | Procedure or surgery | Treatment |
| Sham comparatorSham treatment | Procedure or surgery | Control |
Primary outcome
Change in keratometry
Time frame: 3 Months
1 secondary outcome
Best spectacle-corrected visual acuity
Time frame: 3 Months
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 2 Sep 2010.
- Derived from this study: PubMed 25365551Hallahan KM, Rocha K, Roy AS, Randleman JB, Stulting RD, Dupps WJ Jr. Effects of corneal cross-linking on ocular response analyzer waveform-derived variables in keratoconus and postrefractive surgery ectasia. Eye Contact Lens. 2014 Nov;40(6):339-44. doi: 10.1097/ICL.0000000000000090.
- Click here to contact the investigator site for this study.Link provided by the sponsor.
Related trials for Progressive Keratoconus
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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.
R. Doyle Stulting, MD, PhD principal investigator
Emory Vision; Emory University
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 Corneal collagen in people with Progressive Keratoconus and Corneal Ectasia, run by Emory University at 1 site in United States.
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 2 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 2 Sep 2010. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in keratometry (time frame: 3 Months). 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 NCT00567671, 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 2 Sep 2010.