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Procedure

Nd:YAG Laser Interventional Cohort for Corneal Dystrophy

N/A
Recruiting
Led By Albert S Jun, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of granular corneal dystrophy with presence of granular opacities in the peripheral cornea of appropriate size (ca. 50 µm) in at least one eye
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention day 7, post-intervention 3 months
Awards & highlights

Study Summary

This trial is testing a new treatment for a rare eye disease called Granular Corneal Dystrophy. Currently, the only options for treatment involve surgery. The trial aims to see if a laser

Who is the study for?
This trial is for individuals with Granular Corneal Dystrophy, a rare hereditary eye disease causing vision-impairing deposits in the cornea. Participants must be suitable for minimally-invasive treatment and willing to undergo imaging studies, Nd:YAG laser treatment under local anesthesia, and follow-up visits.Check my eligibility
What is being tested?
The trial tests the effectiveness of Nd:YAG laser therapy as a non-surgical option to remove corneal deposits caused by Granular Corneal Dystrophy. It evaluates if this method can safely disintegrate these depositions without significant side effects.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of laser application, temporary visual disturbances, or infection risks associated with post-treatment antibiotic eye drops.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with granular corneal dystrophy and have visible spots on the edge of my cornea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention day 7, post-intervention 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention day 7, post-intervention 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in size of granular corneal deposits due to Nd:YAG laser treatment
Secondary outcome measures
Safety as the number of participants experiencing decrease in visual acuity
Safety as the number participants experiencing adverse events of inflammation and/or scarring

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nd:YAG Laser Interventional CohortExperimental Treatment1 Intervention
Participants include Granular Corneal Dystrophy patients. On visit 1, participants will undergo visual acuity testing, slit-lamp examination, intra-ocular pressure (IOP) measurement, Scheimpflug tomography, anterior-segment optical coherence tomography (AS-OCT), and slit-lamp photography of the cornea. On the same visit or on a separate visit within 1 month, the participants will undergo the Nd:YAG Laser treatment. At the investigators' discretion, after the procedure, participants might need to administer generic topical antibiotic eye drops three times daily for a week. One week post-intervention (visit 2), the participant will repeat visual acuity testing, slit-lamp examination, IOP measurement, Scheimpflug tomography, AS-OCT, and slit-lamp photography of the cornea. Three months post-intervention (visit 3), the participant will repeat visual acuity testing, slit-lamp examination, IOP measurement, Scheimpflug tomography, AS-OCT, and slit-lamp photography of the cornea.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nd:YAG Laser
2012
N/A
~60

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,492 Total Patients Enrolled
Albert S Jun, MD, PhDPrincipal InvestigatorWilmer Eye Institute/Johns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being admitted to this clinical study?

"Indeed, according to the information provided on clinicaltrials.gov, this ongoing clinical trial is currently accepting applicants. The trial was initially posted on January 26th, 2022 and has been recently updated as of January 1st, 2024. In total, the study aims to enroll a small cohort of only five patients from a single site."

Answered by AI

Is this research study currently accepting new participants?

"Indeed, as per the information available on clinicaltrials.gov, patient recruitment for this study is ongoing. The trial was initially posted on January 26th, 2022 and has been recently updated on January 1st, 2024."

Answered by AI
~1 spots leftby Jan 2025