KeratoconusPhase 1/2NCT02507362
Adapted Fluence Settings for Corneal Collagen Cross-linking in Mild to Moderate Progressive Keratoconus
A Phase 1/2 study testing adjusted corneal collagen cross-linking, accelerated corneal collagen cross-linking and riboflavin 0.1% combined with dextran 20 % in people with Keratoconus, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
the purpose of this study is to compare the efficacy and safety of a new method of corneal cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes) Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- adjusted corneal collagen cross-linking, accelerated corneal collagen cross-linking and riboflavin 0.1% combined with dextran 20 %
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Aug 2014to Feb 2016
- Phase
- Phase 1/2
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild to moderate progressive KCN (Grade I and II) based on Amsler-krumeich classification; progression is defined as the old fashioned way in the lack of a consensus for more modern methods that is increase of > 1D of Kmax readings within 12 months
- Age> 18 y, and <35 years
- Kmax lower than 58 D
- Signing informed consent form
Who cannot join
- Any other ocular disease
- Corneal scar
- History of hydrops
- Any other ocular surgery including previous CCL, corneal inlay or keratorefractive surgery
- Inability to complete follow up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapted Fluence Settings for Corneal Collagen Cross-linking in Progressive Mild to Moderate Keratoconus Aged 18 to 30
the purpose of this study is to compare the efficacy and safety of a new method of corneal cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)
Read the detailed description
This study is a Prospective interventional clinical trial comparing two groups of mild to moderate progressive keratoconic patients; Control group will be treated with routine accelerated protocol of corneal cross-linking, while exposure time will be decreased in the experimental group.
we considered two groups of patients in our study:
- Group 1 (experimental): Exposure to 7 minutes at 9 mW/cm2 = 3.78 J/cm2
- Group 2 (controls): Exposure to 10 minutes at 9 mW/cm2 = 5.4 J/cm2
All demographic data of patients, their uncorrected distance visual acuity (UCDVA), corrected distance visual acuity (BCDVA), sphere and cylinder refraction, keratometry readings (k1 and k2) and other topographic parameters of the patients before the procedure and at every follow up visit will be recorded.
Corneal hysteresis and resistance factor will be checked by Ocular response analyzer before surgery and will be rechecked at 6 month follow up.
Intraoperative pain will also be recorded based on the visual analog scale (VAS + FACES pain scale) immediately after the completion of surgery.
Confocal microscopy will be used to evaluate changes in corneal stromal collagen fibers and keratocytes following cross-linking at 3 and 6 and 12 month post op period.
All procedures will be done by a single surgeon. We will use topical anesthesia by tetracaine followed by mechanical epithelial debridement at a radius of 9 millimeters. Then riboflavin 0.1% combined with dextran 20 % will be instilled every 3 minutes for 25 minutes. A short irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during irradiation) will be performed. Corneal thickness will be determined by ultrasound pachymetry. If needed, hypoosmolar solution will be used to swell the cornea over 400 µm. If 400 µm cannot be reached, then irradiation will not be performed. Then we will irradiate the eye by the UV A light source 5cm away from the eye with a light intensity of 9 mW/cm2 for 10 minutes in control group and 7 minutes in experimental group and riboflavin will be instilled after 5 minutes for further in both groups, followed by a short irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during irradiation).
After the procedure we will apply a bandage contact lens for 5- 7 days and will prescribe topical betamethasone every 6 hours for 2 weeks, tapered to TDS, BID and HS weekly for a total duration 5 weeks. A topical antibiotic drop (Oftaquix every 6 hours) will be used for the first week.
Patients will be followed up at day 1, day 6, 1 month, 3 months and 6 months and 12 months after surgery.
- Conditions
- Keratoconus
- Being tested
- adjusted corneal collagen cross-linking, accelerated corneal collagen cross-linking, riboflavin 0.1% combined with dextran 20 %, epithelial debridement
- Keywords
- keratoconus , corneal collagen cross-linking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjusted corneal collagen cross-linkingRadiation
UV-A irradiation for 7 minutes
accelerated corneal collagen cross-linkingRadiation
UV-A irradiation for 10 minutes
riboflavin 0.1% combined with dextran 20 %Drug
after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation
epithelial debridementProcedure or surgery
Also called epithelium removal
corneal epithelium will be removed by a cottons swab
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Radiation: adjusted corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 7 minutes after 30 mitunes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab Receives: Radiation: adjusted corneal collagen cross-linking; Drug: riboflavin 0.1% combined with dextran 20 %; Procedure: epithelial debridement |
| control | Active comparator | radiation: accelerated corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 10 minutes after 30 minutes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab Receives: Radiation: accelerated corneal collagen cross-linking; Drug: riboflavin 0.1% combined with dextran 20 %; Procedure: epithelial debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratometric values on pentacam measured by Javal keratometer
Measured: one year
best corrected visual acuity
Measured: one year
uncorrected distant visual acuity
Measured: one year
Secondary outcomes (2)
clinical refraction
Measured: one year
endothelial cell count
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fateme Alipour, MD, Principal investigator, Eye research center, Farabi eye hospital, Tehran university of medical science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507362
- Sponsor's protocol ID
- ERC/S/9341
- Status last verified
- Jul 2015
- First submitted
- 6 Aug 2014
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Fluence Settings for Corneal Collagen Cross-linking in Progressive Mild to Moderate Keratoconus Aged 18 to 30
- ClinicalTrials.gov ID
- NCT02507362
- Acronym / sponsor ID
- ERC/S/9341
- Conditions
- Keratoconus
- Keywords
- keratoconus , corneal collagen cross-linking
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 23 Jul 2015 (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 compare the efficacy and safety of a new method of corneal cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)
Detailed description
This study is a Prospective interventional clinical trial comparing two groups of mild to moderate progressive keratoconic patients; Control group will be treated with routine accelerated protocol of corneal cross-linking, while exposure time will be decreased in the experimental group.
we considered two groups of patients in our study:
- Group 1 (experimental): Exposure to 7 minutes at 9 mW/cm2 = 3.78 J/cm2
- Group 2 (controls): Exposure to 10 minutes at 9 mW/cm2 = 5.4 J/cm2
All demographic data of patients, their uncorrected distance visual acuity (UCDVA), corrected distance visual acuity (BCDVA), sphere and cylinder refraction, keratometry readings (k1 and k2) and other topographic parameters of the patients before the procedure and at every follow up visit will be recorded.
Corneal hysteresis and resistance factor will be checked by Ocular response analyzer before surgery and will be rechecked at 6 month follow up.
Intraoperative pain will also be recorded based on the visual analog scale (VAS + FACES pain scale) immediately after the completion of surgery.
Confocal microscopy will be used to evaluate changes in corneal stromal collagen fibers and keratocytes following cross-linking at 3 and 6 and 12 month post op period.
All procedures will be done by a single surgeon. We will use topical anesthesia by tetracaine followed by mechanical epithelial debridement at a radius of 9 millimeters. Then riboflavin 0.1% combined with dextran 20 % will be instilled every 3 minutes for 25 minutes. A short irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during irradiation) will be performed. Corneal thickness will be determined by ultrasound pachymetry. If needed, hypoosmolar solution will be used to swell the cornea over 400 µm. If 400 µm cannot be reached, then irradiation will not be performed. Then we will irradiate the eye by the UV A light source 5cm away from the eye with a light intensity of 9 mW/cm2 for 10 minutes in control group and 7 minutes in experimental group and riboflavin will be instilled after 5 minutes for further in both groups, followed by a short irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during irradiation).
After the procedure we will apply a bandage contact lens for 5- 7 days and will prescribe topical betamethasone every 6 hours for 2 weeks, tapered to TDS, BID and HS weekly for a total duration 5 weeks. A topical antibiotic drop (Oftaquix every 6 hours) will be used for the first week.
Patients will be followed up at day 1, day 6, 1 month, 3 months and 6 months and 12 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Radiation: adjusted corneal collagen cross-linking, Drug: riboflavin 0.1% combined with dextran 20 %, Procedure: epithelial debridementRadiation: adjusted corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 7 minutes after 30 mitunes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab |
| control | Active comparator | Radiation: accelerated corneal collagen cross-linking, Drug: riboflavin 0.1% combined with dextran 20 %, Procedure: epithelial debridementradiation: accelerated corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 10 minutes after 30 minutes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mild to moderate progressive KCN (Grade I and II) based on Amsler-krumeich classification; progression is defined as the old fashioned way in the lack of a consensus for more modern methods that is increase of > 1D of Kmax readings within 12 months
- Age> 18 y, and <35 years
- Kmax lower than 58 D
- Signing informed consent form
Key exclusion criteria (5 listed)
- Any other ocular disease
- Corneal scar
- History of hydrops
- Any other ocular surgery including previous CCL, corneal inlay or keratorefractive surgery
- Inability to complete follow up schedule
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 |
|---|---|---|
| adjusted corneal collagen cross-linkingUV-A irradiation for 7 minutes | Radiation | experimental |
| accelerated corneal collagen cross-linkingUV-A irradiation for 10 minutes | Radiation | control |
| riboflavin 0.1% combined with dextran 20 %after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation | Drug | control, experimental |
| epithelial debridementAlso: epithelium removalcorneal epithelium will be removed by a cottons swab | Procedure or surgery | control, experimental |
Primary outcome
keratometric values on pentacam measured by Javal keratometer
Time frame: one year
best corrected visual acuity
Time frame: one year
uncorrected distant visual acuity
Time frame: one year
2 secondary outcomes
clinical refraction
Time frame: one year
endothelial cell count
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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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.
Fateme Alipour, MD principal investigator
Eye research center, Farabi eye hospital, Tehran university of medical science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing adjusted corneal collagen cross-linking, accelerated corneal collagen cross-linking and riboflavin 0.1% combined with dextran 20 % in people with Keratoconus, run by Tehran University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 5 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 23 Jul 2015. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
keratometric values on pentacam measured by Javal keratometer (time frame: one year). The study lists 3 primary outcomes in all. 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 23 Jul 2015.