Laser Treatment for Corneal Dystrophy

Overseen By Albert S Jun, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Intra-ocular inflammation, Glaucoma, Retinal edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

2 Participants Needed

Trial Summary

What is the purpose of this trial?

Granular Corneal Dystrophy is a rare hereditary disease characterized by the development of deposits within the cornea, which may in turn affect the quality of vision. Still today, all existing treatment options are based on surgical intervention and there is no minimally-invasive treatment available for the disease. The goal of this clinical trial is to test the effectiveness and safety of Neodymium-doped yttrium aluminum garnet (Nd:YAG) laser as a minimally-invasive treatment for people suffering from Granular Corneal Dystrophy. The main question it aims to answer is if Nd:YAG laser is able to disintegrate the characteristic corneal depositions in a safe manner without causing significant adverse effects. If found suitable to be part of the study, participants will first undergo a series of imaging studies to measure and characterize the corneal deposits. After completion, the participants will undergo the Nd:YAG laser treatment under local anesthesia by a corneal specialist, targeting deposits not involving the visual axis. Following the treatment, participants might need to take antibiotic eye drops for a duration of approximately one week. The participants will be required to attend two follow-up visits: one week after the treatment and 3 months after the treatment. In each one of the follow-up visits, an eye examination will be performed and the same series of imaging studies that was performed prior to the Nd:YAG laser treatment will be repeated.

Research Team

Albert S Jun, MD, PhD

Principal Investigator

Wilmer Eye Institute/Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I have been diagnosed with granular corneal dystrophy and have visible spots on the edge of my cornea.

Willingness and ability to give signed informed consent and follow study instructions

Exclusion Criteria

I currently have inflammation inside my eye.

I have glaucoma or swelling in the retina.

I cannot use eye drops by myself or with help.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Assessment

Participants undergo routine ophthalmic examination including visual acuity testing, slit-lamp examination, intra-ocular pressure measurement, and corneal imaging

1 day

1 visit (in-person)

Treatment

Participants undergo Nd:YAG laser treatment under local anesthesia targeting corneal deposits

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat imaging studies and eye examinations

3 months

2 visits (in-person)

Treatment Details

Interventions

• Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) Laser

Trial Overview 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.

Participant Groups

Group I: Nd:YAG Laser Interventional Cohort Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+