NCT05253534Completed
GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma
Pilot Study to Evaluate Clinically the Short-Term Efficacy of GlaucoT Glaucoma Treatment Glasses in the Treatment of Primary Open-Angle Glaucoma (GlaucoT)
Source: ClinicalTrials.gov · Last updated 18 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 2 Feb 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Glaucot Teknoloji Anonim Sirketi
- Diseases
- Glaucoma
- NCT number
- NCT05253534
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Mar 2022 to the primary completion date, 30 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who have undergone intraocular surgery or laser in the last 6 months, excluding those who have had uncomplicated cataract surgery
- Those who have had glaucoma surgery in the past, excluding laser
- Participated in any clinical trial within the previous 30 days.
Other illness
- Those with a history of trauma or inflammation in their eyes
- Presence of any retinal or neurological disease other than glaucoma, abnormal ocular motility preventing binocular fixation (eg, nystagmus, strabismus)
- Those with severe dry eye syndrome
- Those with neurological disorders (eg, epilepsy)
- Those with systemic diseases (eg, diabetic mellitus)
Lab values
- Women who are pregnant supported by biochemical laboratory findings
Age
- Dry/wet type age-related macular degeneration in one or both eyes
Other
- \-
- 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)
- Corneal dystrophies
- High myopia (more than 6 diopters)
- Peripheral retinal degenerations with risk of retinal detachment
- Keratitis
- Patients with difficulties in understanding and adapting to the study
- Negative benefit/risk ratio determined by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ege University Department of Ophthalmology Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Manisa Celal Bayar University Department of Ophthalmology Coordinator of this site? Confirm its status | Manisa | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.