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Showing 1-20 of 62 trials
NCT07390890
This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma. The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT. Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.
NCT07358650
It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system. This medical device includes a sclerectomy punch and injector assembly. It is a multicenter, open-label, non-randomized, single-arm study. Adults aged 40 years or more will be enrolled if the POAG is inadequately controlled by topical drug therapies. Only one eye per subject will be treated. The study will be performed on the first five patients in the operating room and the subsequent 20 patients will be treated under a slit-lamp in an aseptic environment (external patient clinic).Once treated with the MIST device, patients will return the next day, 1 week later and 1, 2, 3, 6, 9 and 12 months later. During these follow-up visits, the ophthalmologist will examine the eye and take measurements of the intraocular pressure.
NCT07235592
The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.
NCT04784234
This study is looking at changes in vision and visual function before and after a six month trial of a daily medical food called GlaucoCetin, formulated with ingredients to support and protect the optic nerve cells. Open angle glaucoma patients will be randomized to receive either a placebo or the medical food for 6 months. We hope to learn if this medical food can improve the vision of our glaucoma patients and to report the findings obtained to the general public.
NCT05902871
The objective of this study is to evaluate the safety and effectiveness of Direct Selective Laser Trabeculoplasty (DSLT) in ethnic Chinese participants with Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT), or Normal Tension Glaucoma (NTG).
NCT07076303
Background Glaucoma is a progressive optic neuropathy characterized by elevated intraocular pressure (IOP), leading to irreversible vision loss. Current treatment strategies often involve medications, which can be challenging for patients due to adherence issues and side effects. Direct Selective Laser Trabeculoplasty (DSLT) represents a potential surgical alternative for managing IOP in patients with naive, untreated glaucoma. This study aims to evaluate the efficacy of DSLT in achieving significant IOP reduction without the need for postoperative medications. Unmet Medical Need: Overview of DSLT Direct Selective Laser Trabeculoplasty (DSLT) is an emerging technology in glaucoma management that combines laser techniques to reduce intraocular pressure (IOP). While it works off the auspices of a previous technology (SLT), the method of delivery is significantly different. Current Research Landscape Most existing studies focus on patients who have already received other forms of treatment or who have more advanced glaucoma. This creates an unmet need to evaluate how DSLT can be effectively integrated into the management of patients at the very beginning of their glaucoma journey. Understanding its efficacy in this population is crucial for establishing best practices and improving long-term outcomes. Interventional Glaucoma Management vs. Standard of Care Standard of care for newly diagnosed glaucoma typically involves medications, such as topical prostaglandin analogs, which can have side effects and may not be effective for all patients. In contrast, interventional glaucoma management-such as DSLT-offers a potentially more direct approach to lowering IOP without the need for ongoing medication. Investigating DSLT in this context could lead to a paradigm shift in how newly diagnosed patients are managed, reducing their reliance on medications and potentially improving adherence and quality of life. Conclusion Addressing this research gap will not only help clarify the role of DSLT in early glaucoma management but could also enhance patient outcomes and guide future treatment protocols. Focusing on newly diagnosed patients is essential for determining the long-term benefits and risks associated with this innovative technology.
NCT06865144
The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.
NCT06978101
This study aimed to assess the correlation between visual field changes and optical coherence tomography (OCT) angiography changes of retinal nerve fiber layer in patients with primary open angle glaucoma.
NCT01742819
Glaucoma is one of the leading causes of blindness in the world. The key to prevention of visual loss from glaucoma is early detection of the disease or its progression and timely treatment. The proposed study will investigate the role of various tests in improving detection of disease progression in advanced glaucoma. Evaluation of the peripheral field of vision (visual field examination) remains the current standard for detection of progression in glaucoma. However, there is a lot of variability or inconsistency in eyes with advanced glaucoma, which could make it difficult to detect worsening of glaucoma with visual fields. The optic nerve demonstrates significant damage in such eyes and hence oftentimes repeat imaging of the optic nerve head is not helpful for detection of change. Therefore, imaging of the central retina (the innermost sensitive tissue lining the inside of the eye), called macula, has been proposed to supplant imaging of the nerve in eyes with severe glaucoma. The macula aids in detailed central vision. Since the macular retinal neural cells are the last ones to be affected in glaucoma, measurement of macular retinal thickness could provide significant information with regard to the course of glaucoma. In the proposed study, glaucoma patients will be tested and followed with various measurements done with newer versions of optical coherence tomography (OCT) imaging and visual field machines. The patients will undergo repeat imaging and visual field testing every 6 months over the course of 5 years. Rates of change will be estimated. We will explore if changes in various outcome measures derived from imaging are correlated with the corresponding visual field changes in glaucoma, and whether the former can be used as an alternative method for detecting simultaneous or subsequent glaucoma progression. The hypothesis for this proposed research is that macular OCT parameters are valid structural measures that can be used especially in advanced disease to follow the course of glaucoma.
NCT05564091
A prospective, multicenter, randomized, single-masked, post-market clinical trial comparing cataract surgery in conjunction with ab-interno canaloplasty utilizing the iTrack Advance canaloplasty device (Nova Eye, Inc.) to cataract surgery only in patients with mild to moderate, primary open angle glaucoma. Subjects will be followed for 24 months.
NCT06407973
A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)
NCT05198297
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure (IOP) in pseudophakic patients with open-angle glaucoma for whom IOP is not sufficiently controlled on topical hypotensive medication and prior to incisional glaucoma surgery.
NCT05557721
Micro pulse transscleral laser treatment (MP-TLT) is a relatively new method to reduce the intraocular pressure (IOP) in glaucoma. New recommendations regarding the treatment protocol has recently been developed and was published 2022. The overall objective is to evaluate the efficacy and safety of the proposed treatment method in an independent study. In addition, the outcome of MP-TLT in patients with pseudoexfoliation glaucoma, which is relatively common in the Nordic countries, and primary open angle glaucoma will be studied separately. The IOP change over the course of one year will be monitored, as well as success rate and survival. Further, patient-reported discomfort from the treatment and the occurrence of any adverse events or complications will be studied.
NCT06223048
The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).
NCT06526416
Evaluation of anterior segment using anterior segment optical coherence tomography in patients undergoing planned bent angle needle goniectomy procedure for uncontrolled open angle glaucoma.
NCT02801617
Aim: To demonstrate the non-inferiority of the PRO-067 ophthalmic solution manufactured by Laboratorios Sophia S.A. de C.V. versus GAAP Ofteno® ophthalmic solution like hypotensive therapy in subjects with primary open angle glaucoma or ocular hypertension. Study design: a multicentric, prospective, crossover (2x2), double blind clinical study. Sample size: one hundred patients with primary open angle glaucoma or ocular hypertension. Patients in the period 1: In the first sequence 60 patients will be assigned to receive the ophthalmic solution: GAAP Ofteno ® (latanoprost 0.005%) 1 drop per day (QD) during 30 days and the second sequence 60 patients will be assigned to receive the ophthalmic solution: PRO-067 1 drop QD during 30 days in the same period. Washout period: 21 hours. Patients in the period 2: the pharmacological intervention change to the opposite therapy for 30 days.
NCT02700984
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
NCT01442896
The purpose of this study is to perform exploratory analyses to evaluate rates of functional and structural change in glaucoma, to identify predictors of rapid progression in patients with glaucoma and to identify possible genetic factors and biomarkers associated with the disease.
NCT06177678
The purpose of this study was to explore the efficacy and safety of the weekly intraocular pressure change of the TFC-003 group and the dorzolamid/timolol combination group in patients with primary open-angle glaucoma or ocular hypertension.
NCT04620135
A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.