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GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma

NCT05253534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-18

No results posted yet for this study

Summary

Glaucoma is a chronic and progressive optic neuropathy characterized by degeneration of ganglion cells and axons with loss of visual function.

It is estimated that glaucoma, which is the second cause of preventable blindness in the world, affects nearly 60 million people worldwide.

The most common type of glaucoma is primary open-angle glaucoma (POAG). POAG is a chronic progressive optic neuropathy with characteristic morphological changes in the optic nerve head and retinal nerve fiber.

POAG, progressive retinal ganglion cell death and visual field loss are associated with these changes.

Risk factors for POAG are age, race, high intraocular pressure (IOP), family history of glaucoma, thin central corneal thickness (CCT), high myopia. IOP is the only modifiable risk factor that we can control. For this reason, the priority in the treatment of POAG has always been to reduce IOP. In glaucoma, the essential point is to preserve the damaged ganglion cell layer and therefore the visual functions. In addition to clinical examination, visual field measurements that measure functions, optical coherence tomography (OCT) thickness measurements that measure anatomical changes, and optic nerve head parameters are the most reliable methods for both diagnosis and evaluation of the efficacy of treatment.

Following the results of the visual field and OCT measurements, it will be tried to determine to what extent glaucoma damage can be ceased by the developed GlaucoT glaucoma treatment glasses.

In this study, it is aimed to measure the effectiveness and safety of flicker light therapy, the effectiveness of which has been investigated in the treatment of Alzheimer's previously and has clinically significant results, with the GlaucoT glaucoma treatment glasses, which was developed to cease visual field loss with patient comfort at the forefront and at a lower cost.

Conditions

  • Primary Open-Angle Glaucoma

Interventions

DEVICE

GlaucoT Glaucoma Treatment Device

In this study, flicker light therapy, the effectiveness of which was investigated in the treatment of glaucoma based on some methods used in different diseases, is described for the first time in glaucoma. Studies investigating the neurodegenerative properties of glaucoma have found similarities in the pathophysiology of Alzheimer's disease and glaucoma. 40 Hz flicker of light Alzheimer 's the positive effects on the knitted cortex have also been shown in studies. 40 Hz flicker light is aimed to reduce glaucoma and retinal ganglion cell loss due to glaucoma, by reducing neurodegeneration by decreasing amyloid and metabolite accumulation by increasing both microglial phagocytic activation effect and retinal blood flow.

Sponsors & Collaborators

  • Glaucot Teknoloji Anonim Sirketi

    lead INDUSTRY

Principal Investigators

  • Ozcan Kayikcioglu, Prof · Manisa Celal Bayar University Department of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05253534 on ClinicalTrials.gov