Progressive KeratoconusPhase 4NCT01485211
Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin
A Phase 4 study testing cross-linking with hypo-osmolar riboflavin in people with Progressive Keratoconus and Thin Corneas, run by Instituto de Olhos de Goiania.
Trial summary
The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Progressive Keratoconus, Thin Corneas
- What is being tested?
- cross-linking with hypo-osmolar riboflavin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Nov 2011
- Phase
- Phase 4
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Progressive Keratoconus
- thin corneas
Who cannot join
- Contact lens use for less than 3 weeks
- Non progressive keratoconus
- Thinest corneal thickness above 400 micra
About this study
Official title: Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Hypo-osmolar Riboflavin Solution in Thin Corneas
The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.
Read the detailed description
To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.
Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.
After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
- Conditions
- Progressive Keratoconus, Thin Corneas
- Being tested
- cross-linking with hypo-osmolar riboflavin
- Keywords
- progressive keratoconus, thin corneas, cross-linking, hypo-osmolar riboflavin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-linking with hypo-osmolar riboflavinDrug
Also called Riboflavin, UVA radiation
Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| crosslinking with hypoosmolar riboflavin | Experimental | Riboflavin and UVA-induced corneal cross-linking increases the stability of keratoconic corneas. The current inclusion criteria require a minimum stromal thickness of 400 µm. Hypo-osmolar riboflavin solution increases the stromal thickness before CXL in cases with preoperatively thin corneas. Receives: Drug: cross-linking with hypo-osmolar riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas
To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking treatment with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas with progressive keratoconus.
Measured: Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 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 2011 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionNov 2011
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01485211
- Sponsor's protocol ID
- BQ - 5 - 11 -ARVO
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nassaralla BA, Vieira DM, Machado ML, Figueiredo MN, Nassaralla JJ Jr. Corneal thickness changes during corneal collagen cross-linking with UV-A irradiation and hypo-osmolar riboflavin in thin corneas. Arq Bras Oftalmol. 2013 May-Jun;76(3):155-8. doi: 10.1590/s0004-27492013000300005.
PubMed 23929075
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Hypo-osmolar Riboflavin Solution in Thin Corneas
- ClinicalTrials.gov ID
- NCT01485211
- Acronym / sponsor ID
- BQ - 5 - 11 -ARVO
- Conditions
- Progressive Keratoconus, Thin Corneas
- Keywords
- progressive keratoconus, thin corneas, cross-linking, hypo-osmolar riboflavin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Dec 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.
The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.
Detailed description
To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.
Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.
After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| crosslinking with hypoosmolar riboflavin | Experimental | Drug: cross-linking with hypo-osmolar riboflavinRiboflavin and UVA-induced corneal cross-linking increases the stability of keratoconic corneas. The current inclusion criteria require a minimum stromal thickness of 400 µm. Hypo-osmolar riboflavin solution increases the stromal thickness before CXL in cases with preoperatively thin corneas. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Progressive Keratoconus
- thin corneas
Key exclusion criteria (3 listed)
- Contact lens use for less than 3 weeks
- Non progressive keratoconus
- Thinest corneal thickness above 400 micra
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 |
|---|---|---|
| cross-linking with hypo-osmolar riboflavinAlso: Riboflavin, UVA radiationHipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months. | Drug | crosslinking with hypoosmolar riboflavin |
Primary outcome
Corneal thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas
Time frame: Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking treatment with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas with progressive 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 5 Dec 2011.
- Derived from this study: PubMed 23929075Nassaralla BA, Vieira DM, Machado ML, Figueiredo MN, Nassaralla JJ Jr. Corneal thickness changes during corneal collagen cross-linking with UV-A irradiation and hypo-osmolar riboflavin in thin corneas. Arq Bras Oftalmol. 2013 May-Jun;76(3):155-8. doi: 10.1590/s0004-27492013000300005.
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.
Belquiz A Nassaralla, MD, PhD study chair
Instituto de Olhos de Goiania
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cross-linking with hypo-osmolar riboflavin in people with Progressive Keratoconus and Thin Corneas, run by Instituto de Olhos de Goiania.
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 2 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 5 Dec 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas (time frame: Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 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 NCT01485211, 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 5 Dec 2011.