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Showing 1-20 of 848 trials
NCT05269680
As part of the post-market clinical follow-up (PMCF), this registry is developed to ensure real-world data collection on MINIject device.
NCT07418853
The goal of this study is to determine of one of three different devices to perform goniotomy to treat glaucoma at the time of cataract surgery is more or less effective than the others. The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery. Participants will under combined cataract surgery and goniotomy. They will have post-operative follow up visits at 1 day, 1 week, 1 month, 3 months, and 6 month
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.
NCT06943599
The goal of this randomized, parallel-group, controlled trial is to compare methods of improving linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening. Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from health workers, or (3) no intervention. The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.
NCT05236439
The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy
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.
NCT05625958
The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy
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.
NCT06819046
A randomized, single-site, parallel-group, prospective study of patients who are candidates for SLT, to study the effect of IOP change with Rocklatan vs artificial tears.
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.
NCT07480577
This study evaluates whether a personalized mobile reminder program improves treatment adherence and clinical outcomes in adults with primary open-angle glaucoma (POAG) using topical antiglaucoma eye drops. Poor adherence to long-term eye-drop therapy is common in glaucoma care and may contribute to inadequate intraocular pressure (IOP) control and disease progression. Participants are randomized to either (1) a digital adherence intervention or (2) standard outpatient follow-up. The intervention consists of daily interactive SMS/WhatsApp medication reminders plus weekly brief educational messages for 3 months. The primary outcome is change in medication adherence measured by the Morisky Medication Adherence Scale-8 (MMAS-8) at month 3. Secondary outcomes include change in IOP, eye-drop instillation technique, and treatment satisfaction. Exploratory analyses assess the relationship between adherence level and OCT-based retinal nerve fiber layer (RNFL) progression metrics. The goal is to determine whether a low-cost, scalable mobile strategy can improve short-term glaucoma management in routine practice.
NCT07480603
A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.
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.
NCT07462000
This observational study will compare proteomic and elemental profiles of aqueous humor and ocular tissues in patients with primary open-angle glaucoma (POAG) and cataract versus cataract controls without glaucoma. Samples collected during standard surgery will be analyzed using LC-MS/MS and ICP-MS. The goal is to identify glaucoma-associated molecular patterns with potential diagnostic or prognostic relevance.
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.
NCT07455786
These procedures include deep non-penetrating sclerectomy, viscocanalostomy, and small incision trabeculectomy, avoiding Tenon's capsule.