Corneal EctasiaNCT01123057
Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia
A study testing riboflavin-induced collagen cross-linking treatment and Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia in people with Corneal Ectasia, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
This is a hospital-based interventional prospective study. Patients with clinical keratoconus or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the eligibility criteria are recruited for this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Ectasia
- What is being tested?
- riboflavin-induced collagen cross-linking treatment and Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2008to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have clinical evidence of keratoconus or LASIK keratectasia (moderate to severe)
- Visual acuity with contact lenses must be better than or equal to 6/12 (20/40).
- Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
- Patients should have a minimum of corneal thickness of 400um (with cornea at swollen state denuded of epithelium during surgery).
- In terms of general health, patients must not have any illnesses posing an immediate threat to life.
- Patients must over 18 years of age.
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- Patients' contact lens wear must be stopped 3 days prior to preop assessment
- Patients can wear their lenses up to the day before the surgery
- Any vitamin C intake must be stopped 1 week prior to surgery
- Both eyes may be recruited if eligible.
- Patients with other non-inflammatory corneal thinning disorders such as pellucid marginal degeneration, keratoglobus and posterior keratoconus may be recruited
Who cannot join
- corneal thickness <400 µm in swollen state
- epithelial healing disorders (e.g. map-dot-fingerprint dystrophy, rheumatic disorders)
- refractive keratotomies
- corneal melting conditions
- herpes keratitis (UV can activate this herpes virus)
- associated systemic disorder such as Down's syndrome
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- Pregnancy
- Breast-feeding.
- Patients with history of herpetic keratitis.
- Patients with autoimmune diseases
- Patients with IOP >21mmHg
- Patients with cataracts
- Patients taking part in other biomedical research in the 30 days prior to the start of this study.
- Patients with alcohol abuse, psychological weakness, or an uncooperative disposition.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Eye Research Institute
Singapore, Singapore, 168751
Yeng Li Goh, 6563224533
Li Lim, FRCS
About this study
This is a hospital-based interventional prospective study. Patients with clinical keratoconus or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the eligibility criteria are recruited for this study. The aim of the study is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia
Read the detailed description
The purpose of this evaluation is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia due to keratoconus and LASIK keratectasia. The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
A thorough examination is performed to evaluate the following pre-operatively:
- Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
- Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
- Slit-lamp biomicroscopy and photography
- Intraocular pressure measurement
- Fundoscopy
- Corneal topography using Orbscan II and Pentacam
- Corneal aberrometry measurement using Technolas Zywave Aberrometer
- Endothelial cell count measurement using Konan noncontact endothelial cell analyser
- Confocal microscopy
- Corneal hysteresis measurement using Ocular Response Analyser
- Subjective feedback about quality of vision (VF 14 assessment) Post-operative Assessment (1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively)
- Uncorrected visual acuity and best corrected visual acuity with manifest refraction
- Cycloplegic refraction results - uncorrected visual acuity and best corrected visual acuity
- Subjective visual outcome rating
- Slit lamp examination and photography
- Fundoscopy
- Corneal topography
- Aberrometry measurement
- Endothelial cell count
- Confocal microscopy
- Corneal hysteresis measurement
- Report adverse events
- Conditions
- Corneal Ectasia
- Being tested
- riboflavin-induced collagen cross-linking treatment, Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia
- Keywords
- keratoconus, collagen cross-linking, LASIK ectasia, keratoconus,lasik ectasia
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
riboflavin-induced collagen cross-linking treatmentProcedure or surgery
The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasiaDevice
Use of riboflavin eyedrops during the procedure Use of UVA device (Peschke Meditrade)
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal topography
The keratometry values will be monitored.
Measured: 1 year
Secondary outcomes (1)
visual acuity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startAug 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corneal EctasiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Li Lim, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123057
- Sponsor's protocol ID
- R573/61/2007
- Status last verified
- May 2010
- First submitted
- 10 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
PubMed 12719068Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
PubMed 20138607
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia
- ClinicalTrials.gov ID
- NCT01123057
- Acronym / sponsor ID
- R573/61/2007
- Conditions
- Corneal Ectasia
- Keywords
- keratoconus, collagen cross-linking, LASIK ectasia, keratoconus,lasik ectasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 14 May 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.
This is a hospital-based interventional prospective study. Patients with clinical keratoconus or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the eligibility criteria are recruited for this study. The aim of the study is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia
Detailed description
The purpose of this evaluation is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia due to keratoconus and LASIK keratectasia. The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.
A thorough examination is performed to evaluate the following pre-operatively:
- Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
- Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
- Slit-lamp biomicroscopy and photography
- Intraocular pressure measurement
- Fundoscopy
- Corneal topography using Orbscan II and Pentacam
- Corneal aberrometry measurement using Technolas Zywave Aberrometer
- Endothelial cell count measurement using Konan noncontact endothelial cell analyser
- Confocal microscopy
- Corneal hysteresis measurement using Ocular Response Analyser
- Subjective feedback about quality of vision (VF 14 assessment) Post-operative Assessment (1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively)
- Uncorrected visual acuity and best corrected visual acuity with manifest refraction
- Cycloplegic refraction results - uncorrected visual acuity and best corrected visual acuity
- Subjective visual outcome rating
- Slit lamp examination and photography
- Fundoscopy
- Corneal topography
- Aberrometry measurement
- Endothelial cell count
- Confocal microscopy
- Corneal hysteresis measurement
- Report adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have clinical evidence of keratoconus or LASIK keratectasia (moderate to severe)
- Visual acuity with contact lenses must be better than or equal to 6/12 (20/40).
- Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
- Patients should have a minimum of corneal thickness of 400um (with cornea at swollen state denuded of epithelium during surgery).
- In terms of general health, patients must not have any illnesses posing an immediate threat to life.
Key exclusion criteria (14 listed)
- corneal thickness <400 µm in swollen state
- epithelial healing disorders (e.g. map-dot-fingerprint dystrophy, rheumatic disorders)
- refractive keratotomies
- corneal melting conditions
- herpes keratitis (UV can activate this herpes virus)
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 |
|---|---|---|
| riboflavin-induced collagen cross-linking treatmentThe principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment. The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application. | Procedure or surgery | – |
| Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasiaUse of riboflavin eyedrops during the procedure Use of UVA device (Peschke Meditrade) | Device | – |
Primary outcome
corneal topography
Time frame: 1 year
The keratometry values will be monitored.
1 secondary outcome
visual acuity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2010.
- Background: PubMed 12719068Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.
- Background: PubMed 20138607Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
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Corneal Elastography and Patient Specific Modeling
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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.
Li Lim principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing riboflavin-induced collagen cross-linking treatment and Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia in people with Corneal Ectasia, run by Singapore National Eye Centre at 1 site in Singapore.
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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 May 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 Singapore. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal topography (time frame: 1 year). 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 NCT01123057, which also lists 2 linked publications.
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 14 May 2010.