Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) Laser Treatment for Granular Corneal Dystrophy

NCT06202651 | Terminated FDA Device

• 1 other identifier: IRB00304623
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Granular Dystrophy, Corneal

Keywords

Granular Dystrophy; Cornea; Nd:YAG Laser; Neodymium-doped Yttrium Aluminum Garnet Laser

Outcome Measures

Primary Outcomes (1)

• Change in size of granular corneal deposits due to Nd:YAG laser treatment

  The size of each one of the two treated corneal deposits per participant will be measured in µm on images taken by both the AS-OCT and slit-lamp photography in each study visit. The size will be measured both manually and automatically on each one of the imaging techniques. A comparison of the size between study visits will be performed, change from day 7 post-intervention to month 3 post-intervention.

  Baseline, Post-intervention day 7, Post-intervention 3 months

Secondary Outcomes (2)

• Safety as the number participants experiencing adverse events of inflammation and/or scarring

  Post-intervention day 7, Post-intervention 3 months

• Safety as the number of participants experiencing decrease in visual acuity

  Baseline, Post-intervention day 7, Post-intervention 3 months

Study Arms (1)

Nd:YAG Laser Interventional Cohort

EXPERIMENTAL

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.

Device: Nd:YAG Laser

Interventions

Nd:YAG Laser DEVICE

Prior to Nd:YAG laser treatment, two drops of topical anesthetic will be administered to the study eye. The two most peripheral deposits that are of ca. 50 µm size will be located and used as the targets for the treatment. The Nd:YAG laser will then be administered to each one of the two deposits, beginning with the lowest energy setting (0.3 mJ) and increasing the energy levels up to to 3 mJ in increments of 0.5 mJ. Five single-burst shots will be performed per laser energy setting per opacity until a visible effect is seen. After the procedure, the eye will be examined to assess the integrity of the corneal epithelium. If a defect is seen, the participant will be advised to administer topical antibiotic eye drops three times daily for a week as a precautionary measure.

Also known as: Optimis II (Quantel Medical)

Nd:YAG Laser Interventional Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age
• 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
• Willingness and ability to give signed informed consent and follow study instructions

You may not qualify if:

• Presence of any active intra-ocular inflammation
• Pre-existing glaucoma or retinal edema
• Cannot properly self-administer or receive an eye drop medication

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute - Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (14)

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  BACKGROUND

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MeSH Terms

Conditions

Corneal Dystrophies, Hereditary; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Albert S Jun, MD, PhD

  Wilmer Eye Institute/Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single interventional group of Granular Corneal Dystrophy participants over the age of 18 years that undergo a single Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) Laser treatment.

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 11, 2024
• Study Start: January 26, 2022
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

US (1)