Bullous KeratopathyC3RNCT01106274
The Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking on the Signs and Symptoms of Bullous Keratopathy
A study testing ultraviolet-A in people with Bullous Keratopathy, run by Mashhad University of Medical Sciences.
Trial summary
Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Bullous Keratopathy
- What is being tested?
- ultraviolet-A
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Sep 2009
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with bollous keratopathy
Who cannot join
- corneal scarring or contemporary eye disease affecting VA were excluded.
About this study
Official title: Study of the Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking
Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy.
- Conditions
- Bullous Keratopathy
- Being tested
- ultraviolet-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultraviolet-ARadiation
Corneal cross linking (C3R) with riboflavin and ultraviolet-A (UVA, 370 nm, 3mW/cm2) for 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startNov 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous KeratopathyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106274
- Sponsor's protocol ID
- MUMS-88191
- Acronym
- C3R
- Status last verified
- Oct 2008
- First submitted
- 16 Apr 2010
- Last updated
- 19 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Riboflavin/ Ultraviolet-A Corneal Cross-linking
- ClinicalTrials.gov ID
- NCT01106274
- Acronym / sponsor ID
- C3R / MUMS-88191
- Conditions
- Bullous Keratopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2008
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Apr 2010 (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.
Recently, riboflavin (0.1%) and ultraviolet-A (UVA) collagen cross-linking (C3R) has shown potential to improve the signs and symptoms of bullous keratopathy .The objective of this study is to demonstrate the effects of C3R to treat bullous keratopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with bollous keratopathy
Key exclusion criteria (1 listed)
- corneal scarring or contemporary eye disease affecting VA were excluded.
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 |
|---|---|---|
| ultraviolet-ACorneal cross linking (C3R) with riboflavin and ultraviolet-A (UVA, 370 nm, 3mW/cm2) for 30 min | Radiation | – |
Primary outcome
Not reported in the source record.
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 19 Apr 2010.
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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 ultraviolet-A in people with Bullous Keratopathy, run by Mashhad University of Medical Sciences.
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 1 inclusion and 1 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 19 Apr 2010. 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.
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 19 Apr 2010.