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Procedure
Corneal Collagen Cross-Linking for Keratoconus
N/A
Recruiting
Led By David Huang, MD, PhD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of keratoconus
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after the cxl procedure
Awards & highlights
Study Summary
This trial will use OCT devices to guide lasers during a corneal procedure in order to improve visual outcomes for patients with keratoconus.
Who is the study for?
This trial is for individuals with keratoconus, a condition that affects the cornea of the eye. Participants must have a minimum corneal thickness of 410 microns and be able to commit to study visits and give informed consent. Those with mature cataracts, difficulty maintaining fixation for imaging, or other eye conditions like glaucoma are excluded.Check my eligibility
What is being tested?
The trial is testing Laser Custom Corneal Collagen Cross-Linking (CXL), which aims to reduce corneal aberrations and improve vision in keratoconus patients. The procedure's effectiveness will be assessed using OCT-guided lasers for precision in corneal smoothing.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, temporary visual disturbances, increased sensitivity to light, dry eyes or potential worsening of vision if complications occur. However, CXL is generally considered safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with keratoconus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after the cxl procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after the cxl procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in best spectacle-corrected visual acuity after laser custom CXL
Secondary outcome measures
Determine CXL demarcation line depth
Trial Design
1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention
OCT-guided custom laser CXL
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
7,385,712 Total Patients Enrolled
5 Trials studying Keratoconus
833 Patients Enrolled for Keratoconus
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,828 Total Patients Enrolled
6 Trials studying Keratoconus
638 Patients Enrolled for Keratoconus
David Huang, MD, PhD5.01 ReviewsPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University
10 Previous Clinical Trials
2,827 Total Patients Enrolled
1 Trials studying Keratoconus
258 Patients Enrolled for Keratoconus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have difficulty keeping your eyes still during OCT imaging.I have been diagnosed with keratoconus.My cataracts limit my vision to worse than 20/40.I am unable to understand and agree to the study's details.I have eye conditions like retinal disease or glaucoma that could affect my vision after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Keratoconus Patient Testimony for trial: Trial Name: NCT03760432 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available spots open to participate in this experiment?
"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting patients and has been since June 20th 2018. The most recent update was on September 22nd 2022 and the research aims to include 100 subjects from one medical site."
Answered by AI
How many participants is this clinical trial utilizing?
"Indeed, the information posted on clinicaltrials.gov affirms that this medical research is actively looking for participants. Initially launched on June 20th 2018, and last updated September 22nd 2022, it requires 100 individuals at 1 site to take part."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Missouri
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I have progressive Keratoconus and received corneal cross linking in my left eye. Upon further testing I have been referred to treat my right eye. Expense is a concern. I want to help others with my condition to prevent further issues and prevent a corneal transplant in my future.
PatientReceived no prior treatments
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