Status:
COMPLETED
GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma
Lead Sponsor:
Glaucot Teknoloji Anonim Sirketi
Conditions:
Primary Open-Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Background: Glaucoma, a neurodegenerative disease, is characterized by the death of retinal ganglion cells and their axons. This damage affects all visual pathways up to the visual center in the brai...
Eligibility Criteria
Inclusion
- 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
- \-
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05253534
Start Date
March 1 2022
End Date
December 30 2023
Last Update
November 18 2024
Active Locations (2)
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1
Ege University Department of Ophthalmology
Izmir, Turkey (Türkiye), 35100
2
Manisa Celal Bayar University Department of Ophthalmology
Manisa, Turkey (Türkiye), 45030