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Trial record 1 of 1 for:    NCT05253534
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GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma (GlaucoT)

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ClinicalTrials.gov Identifier: NCT05253534
Recruitment Status : Recruiting
First Posted : February 23, 2022
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Glaucot Teknoloji Anonim Sirketi

Brief 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.


Condition or disease Intervention/treatment Phase
Primary Open-Angle Glaucoma Device: GlaucoT Glaucoma Treatment Device Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Evaluation of the efficacy and safety of GlaucoT in patients with primary open-angle glaucoma (POAG)
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Clinically the Short-Term Efficacy of GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma (GlaucoT)
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Gamma Rhythm Stimulation Group

Evaluation of the efficacy and safety of GlaucoT in patients with primary open-angle glaucoma (POAG).

In this study, it was planned to investigate the effect of reducing the progression of glaucomatous damage by applying 40 Hz flicker light therapy for 1 hour a day to POAG patients. It is planned to use visual field test, measurements of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) layer thicknesses in optical coherence tomography to investigate the effectiveness of the treatment.

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.


No Intervention: Control Group

This group will be monitored without using the device.The data will be used only for comparison.

Considering the sample size calculations and losses, a total of 60 patients are planned to be included in the study, with 30 patients in each group.




Primary Outcome Measures :
  1. Frequency of the adverse events [ Time Frame: 6 months ]

    In our study, the safety of the GlaucoT glasses with flickering light treatment will be assessed. The purpose of the treatment is to provide neuroprotection with flickering light treatment.

    The primary outcome for safety of the device is the frequency of the adverse events.


  2. The stabilization in visual field test [ Time Frame: 6 months ]

    The second outcome of the clinical trials will be the efficacy of the GlaucoT device. The differences between the patients who use GlaucoT will be compared with the ones that do not use the device under same conditions (e.g. drug use).

    The assessment will be based on visual field test.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 type age-related macular degeneration in one or both eyes
  • Those who have had glaucoma surgery in the past, excluding laser
  • Corneal dystrophies
  • High myopia (more than 6 diopters)
  • Peripheral retinal degenerations with risk of retinal detachment
  • Keratitis
  • Those with severe dry eye syndrome
  • Those with neurological disorders (eg, epilepsy)
  • Those with systemic diseases (eg, diabetic mellitus)
  • Women who are pregnant supported by biochemical laboratory findings
  • Patients with difficulties in understanding and adapting to the study
  • Negative benefit/risk ratio determined by the investigator
  • Participated in any clinical trial within the previous 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05253534


Contacts
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Contact: Abdulkadir Oduncu, MD +905052377410 abdulkadiroduncu@gmail.com
Contact: Ozcan Kayikcioglu, Prof +905368250684 orkayikcioglu@yahoo.com

Locations
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Turkey
Ege University Department of Ophthalmology Recruiting
İzmir, Turkey, 35100
Contact: Suzan Guven Yilmaz, MD    +905058077802    drsuzan2003@yahoo.com   
Manisa Celal Bayar University Department of Ophthalmology Recruiting
Manisa, Turkey, 45030
Contact: Ozcan Kayikcioglu, MD    +905368250684    orkayikcioglu@yahoo.com   
Sponsors and Collaborators
Glaucot Teknoloji Anonim Sirketi
Investigators
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Principal Investigator: Ozcan Kayikcioglu, Prof Manisa Celal Bayar University Department of Ophthalmology
Additional Information:
Publications:
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Responsible Party: Glaucot Teknoloji Anonim Sirketi
ClinicalTrials.gov Identifier: NCT05253534    
Other Study ID Numbers: 2021-169
First Posted: February 23, 2022    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Our clinical research protocol will be shared with other researchers. The results of this clinical study will be published in an academical paper.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Glaucot Teknoloji Anonim Sirketi:
Glaucoma
Neuroprotection
Gamma Rhythm
Non-invasive
Wearable
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases