Refractive Treatment of Early Keratoconus
iDesign Aberrometer for the Refractive Treatment of Early Keratoconus
1 other identifier
interventional
24
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2016
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 25, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedDecember 14, 2015
December 1, 2015
1 year
November 17, 2015
December 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
Intraoperative and postoperative complications
1 year
Study Arms (2)
Sequential group
ACTIVE COMPARATORPhotorefractive keratectomy will be performed 12-18 months after participants had crosslinking
Simultaneous group
ACTIVE COMPARATORPhotorefractive keratectomy and crosslinking will be performed on the same day
Interventions
corneal collagen crosslinking with riboflavin
Used to map wavefront aberration in planning photorefractive keratectomy
Eligibility Criteria
You may qualify if:
- Group 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:
- i. 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Abbott Medical Opticscollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 25, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2019
Last Updated
December 14, 2015
Record last verified: 2015-12