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Showing 1-20 of 747 trials
NCT07567651
Glaucoma is a group of conditions characterised by a progressive loss of retinal ganglion cells (RGCs) and their axons, leading to characteristic changes in the optic nerve head and the retinal nerve fibre layer. If left untreated, the disease has a natural course that can lead to progressive and significant impairment of visual function. Intraocular pressure (IOP) is the main modifiable risk factor for the onset and progression of the disease. The positive effect of surgery on the progression of glaucoma is certainly due to the reduction in IOP levels achieved in the post-operative period, with probable secondary effects on ocular haemodynamics as well. Although IOP reduction is now considered the most potent neuroprotective treatment for glaucoma, it has been shown that good tonometric control may, in some cases, not be sufficient to preserve visual function. There are, in fact, pressure-independent mechanisms involved in the pathogenesis of glaucomatous damage, in which the progressive deterioration and apoptosis of RGCs are linked to mechanisms such as oxidative stress, glutamate neurotoxicity, the inhibition of anterograde transport of neurotrophic factors, and mitochondrial dysfunction. In recent years, various molecules, including cytidine-5'-diphosphocholine (citicoline), have been proposed in combination with hypotensive therapy due to their neuroprotective and neuroenhancing effects. In addition to its structural action, it possesses a functional action (neuroenhancer) as it increases the synthesis of neurotransmitters such as noradrenaline, acetylcholine, serotonin and dopamine, which are involved in visual signal transmission at both the retinal and post-retinal levels. To date, there is no scientific evidence regarding the effect of citicoline on visual function in glaucoma patients who have undergone filtration surgery. Therefore, the hypothesis of this study is that if surgery increases the likelihood of an improvement in the function of residual RGCs, citicoline could help achieve this objective either by increasing the proportion of patients showing improvement or by increasing the extent of the improvement. The use of a placebo is ethically justified because all patients involved in the study, having signed an informed consent form, will undergo surgical treatment - which is considered the treatment of choice for progressive glaucoma - and the efficacy of citicoline treatment needs to be validated in terms of its ability to alter the course of the disease.
NCT05626491
The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.
NCT07539675
Compared with primary angle-closure glaucoma (PACG) patients without zonular laxity and the control group, there are differentially expressed molecules in PACG patients with zonular laxity, and a potential mechanistic network can be constructed therefrom.
NCT06289491
The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are: * How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare? * How do the safety profiles of these three microinvasive glaucoma surgeries compare? Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.
NCT07496957
The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the trabeculectomy in reducing IOP after surgery. The main questions it aims to answer are: Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to trabeculectomy? How do these two surgeries compare over 12 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures? Participants will: Be randomly assigned (1:1) to receive either the trabeculectomy or the PRESERFLO™ MicroShunt during a single glaucoma surgery. Attend scheduled follow-up visits over 12 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments. Receive standard postoperative care and report any complications or additional treatments during the study period.
NCT07488234
Glaucoma is a leading cause of irreversible blindness worldwide, with a higher burden in low- and middle-income countries such as Nepal, where public awareness and treatment adherence remain poor. Lifelong adherence to treatment is important to prevent disease progression but still non adherence remains common. This is a mixed method study which aims to evaluate the effectiveness of structured glaucoma awareness program in improving treatment adherence among glaucoma patients attending a tertiary eye hospital in Nepal. Quantitative assessment will measure changes in treatment adherence using Medication Adherence Scale at baseline and three months post intervention. A qualitative component will explore participants' perceptions of glaucoma program and suggestions for improvement through semi-structured interviews.
NCT07480603
A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.
NCT06053307
In this study, using three phases, the investigators will use an iterative development approach to refine a behavioral intervention for managing concomitant psychosocial distress in glaucoma. Phase 1: The investigators will begin by developing a baseline intervention using strategies from Acceptance and Commitment Therapy (ACT), and delivered using a mobile application. Phase 2: The investigators will refine the baseline intervention for glaucoma patients using qualitative interviews conducted with primary open-angle glaucoma (POAG) patients with psychosocial distress (N=20), and health professionals (N=5). Phase 3: Finally, the investigators will measure acceptability and feasibility of the refined intervention through a single-armed pilot study (N=25). The investigators hypothesize that the refined intervention will yield an acceptable and feasible intervention in a POAG patient population, setting the stage for a future efficacy study.
NCT04354545
To evaluate glaucoma patients' response to treatment with Xiidra, an FDA-approved drug for ocular surface discomfort, which will be prescribed as standard of care treatment.
NCT07465913
This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.
NCT07455786
These procedures include deep non-penetrating sclerectomy, viscocanalostomy, and small incision trabeculectomy, avoiding Tenon's capsule.
NCT07298356
Goldmann Applanation Tonometry (GAT) is considered the clinical gold standard for eye pressure measurements and yet it is known to be a subjective measurement with limited repeatability and limited portability. Another clinical standard for checking eye pressure is known as the pneumotonometer. This method is more objective but not portable. The purpose of this study is to develop new methods of measuring eye pressure that are more objective, reproducible and portable. In this study, the investigators will be comparing the eye pressure measurements using 2 investigational methods to GAT and pneuumotonometer.
NCT07217678
The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
NCT07447011
glaucoma is prevalent among obstructive sleep apnea (OSA). contnous passive airway pressure is main treatment of OSA. lifestyle corrections also recommended
NCT07075718
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
NCT07436871
Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. These visual challenges are particularly relevant when selecting intraocular lenses (IOLs) for glaucoma patients undergoing cataract surgery. Monofocal IOLs are the safest and most commonly used option for glaucoma patients due to their optical simplicity and low incidence of photic phenomena, though they do not provide spectacle independence for near or intermediate vision. Multifocal IOLs (MFIOLs), while offering greater spectacle independence, are relatively contraindicated in glaucoma due to increased visual disturbances like glare and halos. Extended Depth of Focus (EDOF) IOLs offer an intermediate solution, using advanced optics to provide a continuous range of vision and fewer photic disturbances than MFIOLs. EDOF lenses have demonstrated good uncorrected distance and intermediate visual acuity in patients with mild to moderate glaucoma, with promising CS outcomes and high patient satisfaction. However, findings on CS performance remain inconsistent across studies. Given these considerations, this study seeks to determine whether EDOF IOLs can be a viable alternative to monofocal lenses in glaucoma patients, potentially expanding their options for spectacle independence without compromising visual quality. The trial, conducted at OMIQ (Barcelona), will directly compare an EDOF IOL and a monofocal IOL made from the same material to assess their effects on visual acuity, contrast sensitivity, and photic phenomena in this specific patient population.
NCT06190028
The main aim of this investigation is to evaluate the effect of the preservative-free ophthalmic solution IRIDIUM® A gel on the ocular surface of patients with glaucoma or OHT and concomitant DES under multiple long-term topical hypotensive therapy for at least 6 months. The underlying assumption is that ophthalmic solutions as adjuvants for the management of IOP- or glaucoma-associated dry eye may induce a protection of the eye surface with consequent improvement of the symptoms and of the overall quality of life.
NCT07354477
Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG
NCT07425535
Persons who do not have glaucoma will have pictures taken of the optic nerve with a standard camera before and 2 weeks after starting to take a daily glaucoma eye drop to lower eye pressure. These data will be used to compare to the same procedure performed with glaucoma patients to study how glaucoma injures the eye.
NCT07425743
The goal of this clinical trial is to learn if modified non-penetrating deep sclerectomy (NPDS) with a sub-flap mattress suture works to treat open-angle glaucoma (OAG). It will also learn about the safety and effectiveness of this modified surgical approach. The main questions it aims to answer are: Does the modified NPDS technique result in significantly lower and more persistent intraocular pressure (IOP) reduction compared to the conventional technique? What is the rate of complete success (IOP 6-18 mmHg without medication) and qualified success (IOP 6-18 mmHg with medication) for both groups? What postoperative complications or medical problems (such as iris prolapse, conjunctival leaks, or IOP spikes) do participants experience? Researchers will compare Modified Deep Sclerectomy with Ahmed's sub-flap mattress suture to standard conventional NPDS to see which technique provides better long-term pressure control. Participants will be randomized into two groups and will: Undergo either the standard NPDS procedure or the modified NPDS procedure using a 10/0 nylon mattress suture. Visit the clinic for at least five scheduled follow-up appointments at 1 week, 1 month, 3 months, 6 months, and 9 months post-surgery. Undergo comprehensive eye examinations at each visit, including Goldmann applanation tonometry for IOP, visual acuity testing, and monitoring for the development of cataracts or other surgical complications.