Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) Laser Treatment for Granular Corneal Dystrophy
NCT ID: NCT06202651
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2022-01-26
2024-12-09
Brief Summary
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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.
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Detailed Description
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Granular corneal dystrophy (GCD) is a rare hereditary condition characterized by progressive deposition of insoluble protein aggregates in the cornea. The small, white-greyish granular deposits typically begin to form during childhood and grow in size and number with increasing age, eventually coalescing and causing significant visual impairment.
Still today, there is no minimal-invasive treatment available for GCD patients. Current treatment approaches include partial or full-thickness corneal transplant, which is associated with a relatively high recurrence rate and potentially sight-threatening complications. In addition, there is a global shortage of available donor corneas. Therefore, there is an unmet need for a minimal-invasive treatment that could reduce this indication for corneal transplantation and provide symptomatic relief to GCD patients.
As modern Nd:YAG laser systems can focus on a spot size as small as 8-10 µm in different depths of the cornea, the study team hypothesize that the Nd:YAG laser would be capable of accurately targeting the GCD deposits and serve as a viable minimal-invasive treatment option for this disease.
Hence, in the proposed research, the investigators seek to evaluate the efficacy and safety of the Nd:YAG laser in the treatment of GCD patients. If found to be efficacious and safe, the investigators hypothesize that GCD patients will benefit from both the minimal-invasive form of treatment and prompt improvement in quality of life and vision.
During the study, as part of the initial assessment, the participants will undergo routine ophthalmic examination including visual acuity testing, slit-lamp examination, intra-ocular pressure measurement, and corneal imaging including Scheimpflug tomography (Pentacam®), anterior-segment optical coherence tomography (AS-OCT), and slit-lamp photography of the cornea (visit 1). All the above imaging modalities are non-contact, take seconds to perform, and represent no risk to the participant.
Following the initial assessment, the Nd:YAG laser procedure will be performed on the same day (visit 1) or on a separate date (visit 2) depending on the time schedule of both the participant and the research team. One eye will be included in the study per participant. If the severity of the disease is asymmetrical, the eye with more extensive corneal deposition will be included. If the severity is symmetrical, the participant's non-dominant eye will be included as determined by the standard dominance testing method.
Using the slit-lamp, the primary investigator, a corneal specialist, will find the two most peripheral deposits that are of ca. 50 µm size. The width of the thinnest slit-lamp beam, which is 1 mm, will be used as a guide to estimate the deposits' size. The exact size of each opacity will be measured using the images taken by the AS-OCT and slit-lamp photography.
Prior to the Nd:YAG laser treatment, two drops of topical anesthetic will be administered to the study eye to anesthetize the eye, as is always done prior to any other Nd:YAG procedure. The treatment will be delivered using an Optimis II device (Quantel Medical). This is an FDA-approved device used regularly for other ocular indications, that due to its adherence to Non-Significant Risk (NSR) criteria, received an abbreviated Investigational Device Exemption (IDE) approval by the institutional review board (IRB) for the purpose of this study. Typically, a single-pulse Nd:YAG laser energy levels of 2-3 mJ is sufficient to treat posterior capsule opacification, while 2-8 mJ of energy is used to perform an iridotomy. In this research, the primary investigator will begin with the lowest energy setting (0.3 mJ) and increase the energy levels 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. The investigators hypothesize minor risks of corneal scarring or intraocular inflammation after the laser treatment. The participants' visual acuity should not be affected as only peripheral deposits that lie outside the visual axis will be subjected to treatment in this research.
The participant will return one week (visit 2 or 3) and three months (visit 3 or 4) later for follow-up at which the participant will repeat the clinical examination and imaging studies included above. The study cornea will be examined carefully for any signs of inflammation or scarring. The size of the opacities that were treated with Nd:YAG laser will be re-measured using the images taken by the anterior-segment OCT and slit-lamp photography. After the last follow-up examination, the participants will be referred to routine care.
During the entire course of the study, confidentiality will be ensured using standard procedures including storage of study data on password protected computers utilizing a Secure Analytic Framework Environment (SAFE) desktop. Participants will be assigned study identification codes that will be used for all subsequent study procedures.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Nd:YAG Laser Interventional Cohort
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.
Nd:YAG Laser
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.
Interventions
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Nd:YAG Laser
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Pre-existing glaucoma or retinal edema
* Cannot properly self-administer or receive an eye drop medication
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Albert S Jun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wilmer Eye Institute/Johns Hopkins University
Locations
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Wilmer Eye Institute - Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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References
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Aron-Rosa D. Use of a pulsed neodymium-Yag laser for anterior capsulotomy before extracapsular cataract extraction. J Am Intraocul Implant Soc. 1981 Fall;7(4):332-3. doi: 10.1016/s0146-2776(81)80029-8. No abstract available.
Fankhauser F, Lortscher H, van der Zypen E. Clinical studies on high and low power laser radiation upon some structures of the anterior and posterior segments of the eye. Experiences in the treatment of some pathological conditions of the anterior and posterior segments of the human eye by means of a Nd:YAG laser, driven at various power levels. Int Ophthalmol. 1982 May;5(1):15-32. doi: 10.1007/BF00129992.
Vogel A, Busch S, Jungnickel K, Birngruber R. Mechanisms of intraocular photodisruption with picosecond and nanosecond laser pulses. Lasers Surg Med. 1994;15(1):32-43. doi: 10.1002/lsm.1900150106.
Jagger JD. The Nd-YAG Laser in Ophthalmology: Principles and Clinical Applications of Photodisruption. Br J Ophthalmol. 1986;70(1):79.
Blumenkranz MS. The evolution of laser therapy in ophthalmology: a perspective on the interactions between photons, patients, physicians, and physicists: the LXX Edward Jackson Memorial Lecture. Am J Ophthalmol. 2014 Jul;158(1):12-25.e1. doi: 10.1016/j.ajo.2014.03.013. Epub 2014 Mar 31.
Ficker LA, Steele AD. Complications of Nd:YAG laser posterior capsulotomy. Trans Ophthalmol Soc U K (1962). 1985;104 ( Pt 5):529-32.
Karahan E, Er D, Kaynak S. An Overview of Nd:YAG Laser Capsulotomy. Med Hypothesis Discov Innov Ophthalmol. 2014 Summer;3(2):45-50.
Munier FL, Frueh BE, Othenin-Girard P, Uffer S, Cousin P, Wang MX, Heon E, Black GC, Blasi MA, Balestrazzi E, Lorenz B, Escoto R, Barraquer R, Hoeltzenbein M, Gloor B, Fossarello M, Singh AD, Arsenijevic Y, Zografos L, Schorderet DF. BIGH3 mutation spectrum in corneal dystrophies. Invest Ophthalmol Vis Sci. 2002 Apr;43(4):949-54.
Weiss JS, Moller HU, Aldave AJ, Seitz B, Bredrup C, Kivela T, Munier FL, Rapuano CJ, Nischal KK, Kim EK, Sutphin J, Busin M, Labbe A, Kenyon KR, Kinoshita S, Lisch W. IC3D classification of corneal dystrophies--edition 2. Cornea. 2015 Feb;34(2):117-59. doi: 10.1097/ICO.0000000000000307.
Ellies P, Renard G, Valleix S, Boelle PY, Dighiero P. Clinical outcome of eight BIGH3-linked corneal dystrophies. Ophthalmology. 2002 Apr;109(4):793-7. doi: 10.1016/s0161-6420(01)01025-9.
Seitz B, Behrens A, Fischer M, Langenbucher A, Naumann GO. Morphometric analysis of deposits in granular and lattice corneal dystrophy: histopathologic implications for phototherapeutic keratectomy. Cornea. 2004 May;23(4):380-5. doi: 10.1097/00003226-200405000-00013.
Lopes-Ferreira D, Neves H, Queiros A, Faria-Ribeiro M, Peixoto-de-Matos SC, Gonzalez-Meijome JM. Ocular dominance and visual function testing. Biomed Res Int. 2013;2013:238943. doi: 10.1155/2013/238943. Epub 2013 Nov 11.
Bhargava R, Kumar P, Prakash A, Chaudhary KP. Estimation of mean ND: Yag laser capsulotomy energy levels for membranous and fibrous posterior capsular opacification. Nepal J Ophthalmol. 2012 Jan-Jun;4(1):108-13. doi: 10.3126/nepjoph.v4i1.5861.
Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. doi: 10.1016/0039-6257(87)90092-0.
Other Identifiers
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IRB00304623
Identifier Type: -
Identifier Source: org_study_id
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