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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment called Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) to determine its safety in breaking down eye deposits caused by Granular Corneal Dystrophy, a condition that affects vision. Researchers aim to discover if this laser treatment offers a safer, less invasive alternative to surgery. Individuals diagnosed with Granular Corneal Dystrophy and specific eye deposits (not affecting central vision) may be suitable for this study. Participants will undergo eye checks before and after treatment and may need to use antibiotic eye drops for a week. As an unphased trial, this study provides patients the chance to contribute to groundbreaking research that could lead to safer treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this laser treatment is safe for corneal dystrophy?

Research has shown that the Nd:YAG laser is generally safe for eye treatments. It often improves vision after cataract surgery and is well-tolerated by patients. One study found that this laser can safely treat new blood vessel growth on the cornea, with only minor side effects reported.

Although the Nd:YAG laser is not yet approved specifically for Granular Corneal Dystrophy, its use in other eye conditions suggests safety. Participants should know that the laser is minimally invasive, meaning it doesn't require major surgery. Side effects are usually mild and temporary. However, discussing any concerns with the medical team conducting the trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for corneal dystrophy, which often involve surgical procedures like corneal transplants or phototherapeutic keratectomy, the Nd:YAG laser treatment offers a less invasive option. This laser treatment specifically targets and breaks down the deposits in the cornea, potentially improving vision without the need for more invasive surgery. Researchers are excited because it could provide quicker recovery times and reduce the risks associated with surgical intervention, offering a fresh approach to managing corneal dystrophy.

What evidence suggests that the Nd:YAG laser is effective for Granular Corneal Dystrophy?

Research has shown that the Nd:YAG laser effectively improves vision after cataract surgery by clearing cloudiness. In this trial, researchers are testing the Nd:YAG laser for treating Granular Corneal Dystrophy by breaking down deposits in the eye without surgery. Although specific data for this use is limited, the laser's success in other eye conditions suggests potential effectiveness here as well. Early results from other studies indicate that the Nd:YAG laser can be safely used in eye treatments, offering hope for its success in this new application. ^{1 2 3 4 5}

Who Is on the Research Team?

Albert S Jun, MD, PhD

Principal Investigator

Wilmer Eye Institute/Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06202651

Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) ... 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 ...

2. bmjophth.bmj.com bmjophth.bmj.com/content/10/1/e001734

Safety and efficacy of frequency-doubled Nd-YAG laser ... Our study aims to evaluate safety and efficacy of frequency-doubled Nd-YAG laser for photocoagulation of corneal neovascularisation (NLPC).

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06202651/neodymium-doped-yttrium-aluminum-garnet-ndyag-laser-treatment-for-granular-corneal-dystrophy

Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10662619/

Nd:YAG Laser Capsulotomy: Efficacy and Outcomes ... The neodymium-doped yttrium aluminum garnet (Nd:YAG) 1064-nm laser capsulotomy procedure has a long track record of improving visual acuity with low risk of ...

5. researchgate.net researchgate.net/publication/396799753_Neodymium_Doped_Yttrium_Aluminum_Garnet_Nd_YAG_Laser_Physics_in_Ophthalmology

(PDF) Neodymium Doped Yttrium Aluminum Garnet (Nd For instance, it is used to treat posterior capsular opacification (PCO) following cataract surgery and to perform peripheral iridotomy in angle ...