KeratoconusPhase 3NCT02613780
Refractive Treatment of Early Keratoconus
A Phase 3 study testing Crosslinking, Photorefractive keratectomy and iDesign® Advanced WaveScan Studio in people with Keratoconus, run by Ottawa Hospital Research Institute.
Trial summary
Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to significant visual deterioration over time. Corneal collagen crosslinking with riboflavin (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the need for corneal transplantation. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Crosslinking, Photorefractive keratectomy and iDesign® Advanced WaveScan Studio
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2019
- Phase
- Phase 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Group 1:
- 1. Patients with confirmed diagnosis of keratoconus in Krumeich stage 1 or 2 who have received crosslinking 12-18 months prior, with follow up of at least 12 months
- Group 2:
- Diagnosis of keratoconus confirmed based on clinical examination findings and corneal topography
- Evidence of progression of keratoconus occurring over the last 12 months defined as:
- An increase of maximum keratometry reading by 1 diopter or more (≥ 1 D), or ii. Evidence of clinical progression
- Age between 21 and 60 years
- Eyes satisfying all of Krumeich stage 1 or 2 criteria listed below i. Stage 1: eccentric corneal bulging, myopia, and/or astigmatism <5 D and corneal radius ≤48 D, no corneal opacities ii. Stage 2: myopia and/or astigmatism >5 D and <8 D and/or corneal radius ≤53 D, no central opacities, pachymetry ≥400 μm
Who cannot join
- Age less than 21 years, or older than 60 years
- Pregnant, or planning to become pregnant, or breastfeeding
- Past history of Herpes Simplex Keratitis or corneal surgery (other than crosslinking)
- Thin Cornea (<425 microns)
- Other corneal disease, corneal scarring
- History of chemical burns to the cornea or known healing problems
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- Known allergy to Riboflavin (vitamin B2)
- If patient suffers from nystagmus or any other condition that would render it difficult for the patient to hold a steady gaze
- Very advanced corneal ectasia (beyond Krumeich stage 2)
- Poor visual potential
- Vitamin C supplements within 1 week of the procedure
- Lenticular changes (cataracts)
- Programmed PRK treatment exceeding 50 microns in tissue depth
Trial locations and contacts
No sites are listed yet.
Setareh Ziai, MD, FRCSC contact
About this study
Official title: iDesign Aberrometer for the Refractive Treatment of Early Keratoconus
Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to significant visual deterioration over time. Corneal collagen crosslinking with riboflavin (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the need for corneal transplantation. However, the treatment alone has little impact in terms of improving visual function. Photorefractive keratectomy (PRK) is the application of an excimer laser to treat a patient's refractive error, therefore decreasing the dependence on spectacles or contact lenses for improved vision.
Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to partially correct the refractive error in keratoconic patients, whilst simultaneously stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced high-resolution aberrometer. It is capable of mapping highly aberrated corneas for wavefront-guided laser procedures, and represents an important technological advance in treating corneal disease.
The purpose of this single center, prospective pilot study is to assess the safety and efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using the iDesign® aberrometer. Results of this pilot study will be used to provide sample size estimates for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes.
Read the detailed description
The purpose of this pilot study is to assess the visual outcomes of combined wavefront-guided PRK and CXL in Krumeich stage 1 and 2 keratoconic eyes. The investigators will be conducting a prospective study at the University of Ottawa Eye Institute. A total of 24 patients will be enrolled in the study divided into two groups:
Group 1: PRK performed12-18 months after CXL; Group 2: PRK performed or on the same day as CXL
Participants will be followed at regular intervals for 1 year and information regarding visual, refractive, keratometric and higher order aberration outcomes will be collected.
The researchers aim to investigate the safety and efficacy of combined wavefront guided PRK and CXL. Results of this pilot study will used to provide estimates for sample size calculation for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes.
- Conditions
- Keratoconus
- Being tested
- Crosslinking, Photorefractive keratectomy, iDesign® Advanced WaveScan Studio
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrosslinkingProcedure or surgery
corneal collagen crosslinking with riboflavin
Photorefractive keratectomyProcedure or surgery
iDesign® Advanced WaveScan StudioDevice
Used to map wavefront aberration in planning photorefractive keratectomy
| Study group | Role | What they receive |
|---|---|---|
| Sequential group | Active comparator | Photorefractive keratectomy will be performed 12-18 months after participants had crosslinking Receives: Procedure: Crosslinking; Procedure: Photorefractive keratectomy; Device: iDesign® Advanced WaveScan Studio |
| Simultaneous group | Active comparator | Photorefractive keratectomy and crosslinking will be performed on the same day Receives: Procedure: Crosslinking; Procedure: Photorefractive keratectomy; Device: iDesign® Advanced WaveScan Studio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in best-corrected visual acuity at followups
Best-corrected visual acuity (BCVA) will be measured in logMAR. Preoperative BCVA will be compared to BCVA postoperatively and at followups over 1 year using paired t tests.
Measured: 1 year
Secondary outcomes (1)
Intraoperative and postoperative complications
Number of patients with unexpected complications, as well as the type of complication will be collected over 1 year of followups.
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 posted25 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2019 (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.
- More trials run by Ottawa Hospital Research InstituteThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Optics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613780
- Sponsor's protocol ID
- 20150570-01H
- Status last verified
- Dec 2015
- First submitted
- 17 Nov 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iDesign Aberrometer for the Refractive Treatment of Early Keratoconus
- ClinicalTrials.gov ID
- NCT02613780
- Acronym / sponsor ID
- 20150570-01H
- Conditions
- Keratoconus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Abbott Medical Optics
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 25 Nov 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.
Keratoconus is a bilateral, progressive corneal degenerative disorder that often leads to significant visual deterioration over time. Corneal collagen crosslinking with riboflavin (CXL) was developed as a treatment to halt the progression of keratoconus and thus negate the need for corneal transplantation. However, the treatment alone has little impact in terms of improving visual function. Photorefractive keratectomy (PRK) is the application of an excimer laser to treat a patient's refractive error, therefore decreasing the dependence on spectacles or contact lenses for improved vision.
Corneal collagen crosslinking combined with photorefractive keratectomy has been explored to partially correct the refractive error in keratoconic patients, whilst simultaneously stabilizing the corneal changes. Recently, the iDesign® Advanced WaveScan Studio (iDesign system; Abbot Medical Optics; Santa Ana, CA) has been launched as the most advanced high-resolution aberrometer. It is capable of mapping highly aberrated corneas for wavefront-guided laser procedures, and represents an important technological advance in treating corneal disease.
The purpose of this single center, prospective pilot study is to assess the safety and efficacy of combined wavefront-guided PRK and CXL in patients with early keratoconus using the iDesign® aberrometer. Results of this pilot study will be used to provide sample size estimates for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes.
Detailed description
The purpose of this pilot study is to assess the visual outcomes of combined wavefront-guided PRK and CXL in Krumeich stage 1 and 2 keratoconic eyes. The investigators will be conducting a prospective study at the University of Ottawa Eye Institute. A total of 24 patients will be enrolled in the study divided into two groups:
Group 1: PRK performed12-18 months after CXL; Group 2: PRK performed or on the same day as CXL
Participants will be followed at regular intervals for 1 year and information regarding visual, refractive, keratometric and higher order aberration outcomes will be collected.
The researchers aim to investigate the safety and efficacy of combined wavefront guided PRK and CXL. Results of this pilot study will used to provide estimates for sample size calculation for an extension of the study, which aims to determine whether sequential or same day procedure leads to better outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential group | Active comparator | Procedure: Crosslinking, Procedure: Photorefractive keratectomy, Device: iDesign® Advanced WaveScan StudioPhotorefractive keratectomy will be performed 12-18 months after participants had crosslinking |
| Simultaneous group | Active comparator | Procedure: Crosslinking, Procedure: Photorefractive keratectomy, Device: iDesign® Advanced WaveScan StudioPhotorefractive keratectomy and crosslinking will be performed on the same day |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 1. Patients with confirmed diagnosis of keratoconus in Krumeich stage 1 or 2 who have received crosslinking 12-18 months prior, with follow up of at least 12 months
- Diagnosis of keratoconus confirmed based on clinical examination findings and corneal topography
- Evidence of progression of keratoconus occurring over the last 12 months defined as:
- Age between 21 and 60 years
- Eyes satisfying all of Krumeich stage 1 or 2 criteria listed below i. Stage 1: eccentric corneal bulging, myopia, and/or astigmatism <5 D and corneal radius ≤48 D, no corneal opacities ii. Stage 2: myopia and/or astigmatism >5 D and <8 D and/or corneal radius ≤53 D, no central opacities, pachymetry ≥400 μm
Key exclusion criteria (13 listed)
- Age less than 21 years, or older than 60 years
- Pregnant, or planning to become pregnant, or breastfeeding
- Past history of Herpes Simplex Keratitis or corneal surgery (other than crosslinking)
- Thin Cornea (<425 microns)
- Other corneal disease, 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 |
|---|---|---|
| Crosslinkingcorneal collagen crosslinking with riboflavin | Procedure or surgery | Sequential group, Simultaneous group |
| Photorefractive keratectomy | Procedure or surgery | Sequential group, Simultaneous group |
| iDesign® Advanced WaveScan StudioUsed to map wavefront aberration in planning photorefractive keratectomy | Device | Sequential group, Simultaneous group |
Primary outcome
Improvement in best-corrected visual acuity at followups
Time frame: 1 year
Best-corrected visual acuity (BCVA) will be measured in logMAR. Preoperative BCVA will be compared to BCVA postoperatively and at followups over 1 year using paired t tests.
1 secondary outcome
Intraoperative and postoperative complications
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 Dec 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.
Setareh Ziai, MD, FRCSC contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crosslinking, Photorefractive keratectomy and iDesign® Advanced WaveScan Studio in people with Keratoconus, run by Ottawa Hospital Research Institute.
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 8 inclusion and 13 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 Dec 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Setareh Ziai, MD, FRCSC (ziaieye@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in best-corrected visual acuity at followups (time frame: 1 year). 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 14 Dec 2015.