CompletedNot Applicable

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

Turkey (Türkiye)15 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria for subject selection * Those who have applied to the eye diseases clinic * ≥18 years old * Those diagnosed with primary open-angle glaucoma (POAG) before the study * Recipients of standard drug therapy (defined in diagnostic and treatment guidelines) for POAG * Patients deemed appropriate by the investigator to be included in the study after ophthalmological examination * According to the results of intraocular pressure (IOP) measurement and visual field test, patients with target pressure and initial moderate visual field loss who were deemed appropriate for inclusion in the study by the investigator * Patients who were informed about the study and agreed to participate in the study * Those who agree to continue to use acceptable methods of contraception during the study Exclusion Criteria: \- Exclusion criteria for selection of subjects * Those with a history of trauma or inflammation in their eyes * Those who have undergone intraocular surgery or laser in the last 6 months, excluding those who have had uncomplicated cataract surgery * Presence of any retinal or neurological disease other than glaucoma, abnormal ocular motility preventing binocular fixation (eg, nystagmus, strabismus) * Those with corneal transplants * Advanced disc cupping (c/d ratio 0.8 and above) * Large and severe perimetric defects (a central perimetric residual not greater than 10 central degrees) * Advanced visual field damage (MD above 12 db) * Dry/wet t…

What they're measuring

Frequency of the adverse events

Timeframe: 6 months

The stabilization in visual field test

Timeframe: 6 months

Trial details

NCT IDNCT05253534

SponsorGlaucot Teknoloji Anonim Sirketi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-30