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Glaucoma clinical trials

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NCT ID: NCT05625958 Not yet recruiting - Clinical trials for Glaucoma, Open-Angle

Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

SAFARI4
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05593354 Not yet recruiting - Glaucoma Clinical Trials

MicroPulse TLT - UK Study

MPTLTUKS
Start date: May 1, 2023
Phase:
Study type: Observational [Patient Registry]

This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.

NCT ID: NCT05581498 Not yet recruiting - Glaucoma Clinical Trials

Glaucoma Exercise as Medicine Study (GEMS).

GEMS
Start date: September 2024
Phase: N/A
Study type: Interventional

Project Summary Abstract: While lifestyle changes, particularly exercise, have been suggested to protect against damage to ganglion cells in animal models, definitive evidence demonstrating its benefits in humans is lacking. Here, in a group of individuals with ganglion cell damage from glaucoma and a separate control group without significant eye disease, the investigators study the effects of a remotely delivered exercise training program by a trained exercise physiologist consisting of resistance training combined with cycling on a stationary bike. Three outcomes will be examined to evaluate if exercise might be of potential long-term benefit in protecting ganglion cells. In Aim 1, the investigators will examine the trial's primary outcome, a comparison of the pointwise change in the visual field (VF) sensitivity over the exercise period compared to a preceding usual activity period. Given the subjective nature of VF testing, Electroretinogram (ERG) testing will be employed as a more objective secondary outcome. Together, these outcomes will determine if neuro recovery is possible with exercise in individuals with GC damage from glaucoma (as has been demonstrated for Intraocular pressure (IOP)-lowering and, more recently, nicotinamide) and if neuro enhancement (improvement in the function above an already-normal level) is possible in adults without eye disease. In Aim 2, the investigators will examine if an exercise produces physiologic changes in the human eye (glaucoma and control), which would give mechanistic plausibility for a neuroprotective effect. Specifically, the investigators will compare exercise-induced changes in large vessel retinal blood flow, the density of and flux within perfused capillaries, large-vessel arterial-venous oxygen (O2) saturation gradients, inner retinal O2 metabolism, and serum levels of brain-derived neurotrophic factor (BDNF) to changes occurring in the preceding usual activity control period. Finally, in Aim 3, the investigators will examine if exercise benefits quality of life (QOL) in individuals with VF damage from glaucoma within specific domains (mobility, ocular discomfort, and mood) independent of changes in visual function. Together, these findings will provide important information regarding whether exercise produces short-term changes in eyes, which suggests possible long-term protection against ganglion cell damage.

NCT ID: NCT05575154 Not yet recruiting - Glaucoma Clinical Trials

ISNT Rule in Normal Population

Start date: December 1, 2022
Phase:
Study type: Observational

This study sought to determine the percentage of normal eyes that followed the ISNT rule by retinal nerve fiber layer (RNFL) and neuroretinal rim thickness measurements using optical coherence tomography (OCT) , and secondarily, whether alternative rules may be more applicable or easily generalized.

NCT ID: NCT05542290 Not yet recruiting - Glaucoma Clinical Trials

Implantation of Capsular Tension Ring in Primary Angle Closure Patients With Zonular Laxity or Dialysis

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Primary angle closure glaucoma (PACG) is the main type of glaucoma in China, which includes acute and chronic PACG. According to the International Society of Geographical and Epidemiological Ophthalmology (ISGEO), this spectrum of disease is divided into acute angle closure crisis (AACC), primary angle closure suspect (PACS), primary angle closure (PAC) and PACG. Previous researchers have reported that with the wider use of lens extraction and intraocular lens (IOL) implantation combined with anti-glaucoma surgery in the treatment of PAC and PACG, the prevalence of zonular laxity or dialysis in primary angle closure disease (PACD) was found to be relatively high. In one of the studies performed by the investigators, the proportion of zonular laxity or dialysis was 46.2%, significantly higher than that in the age-related cataract patients (control group), which was 6.0%. In PACD patients with zonular laxity or dialysis, whether or not should the investigators implant capsular tension ring (CTR), the efficacy and safety of CTR implantation, and if there is any difference in the prevalence of complications during and after surgery between patients with and without CTR implantation remain unclear. The purpose of this study was to investigate the efficacy and safety of CTR implantation in PACD patients with zonular laxity and zonular dialysis ≤ 4 clocks.

NCT ID: NCT05530031 Not yet recruiting - Glaucoma Pediatric Clinical Trials

UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma

UBM
Start date: September 2022
Phase: N/A
Study type: Interventional

Different types of surgery are applied in PCG, including goniotomy, trabeculotomy, glaucoma drainage devices and trabeculectomy. UBM examination of the anterior chamber before surgery can help in the decision to what type of surgery is best for the patient. Aim of the work To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.

NCT ID: NCT05484050 Not yet recruiting - Iris Clinical Trials

VEGF in Iris Tissue in Primary Congenital Glaucoma

Start date: September 2022
Phase: N/A
Study type: Interventional

Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.

NCT ID: NCT05426044 Not yet recruiting - Glaucoma Clinical Trials

Metformin as a Neuroprotective Therapy for Glaucoma - A Randomized Controlled Trial

Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

Glaucoma, a chronic degenerative disease of the optic nerve, is the leading cause of irreversible blindness worldwide. Although lowering the intraocular pressure (IOP) has been shown to be effective to slow optic nerve degeneration, a significant portion of glaucoma patients continue to develop progressive loss in vision despite adequate control of IOP. Development of neuroprotective therapy to prevent optic nerve degeneration by mechanisms other than IOP- lowering is critical to reduce the burden of glaucoma blindness. With 76 million glaucoma patients in 2020 worldwide, the need to investigate neuroprotection for glaucoma is pressing. While metformin is a widely adopted oral hypoglycemic medication for treatment of type 2 diabetes mellitus (DM), increasing evidence from clinical studies has shown that metformin can decrease the risk of many age-related diseases including neurodegenerative diseases. In a retrospective study of 150,016 patients with DM, those taking metformin at >1500mg/day had a 25% reduced risk of development of open-angle glaucoma than those who took no metformin. Metformin has a high safety profile. We aim to investigate whether metformin can be repurposed to a neuroprotective therapy for glaucoma patients in a randomized controlled trial. We propose to conduct a 24-month, double-blind, placebo-controlled, parallel group, multi- center trial, randomizing 240 primary open angle glaucoma patients who have progressive retinal nerve fiber layer ganglion cell inner plexiform layer (RNFL-GCIPL) thinning in at least one eye, as determined by wide-field optical coherence tomography Trend-based Progression Analysis, to receive metformin 1500mg/day or placebo. All patients will be followed up at 2- month intervals for IOP, RNFL-GCIPL thickness, and visual field (VF) measurements. The objectives are to compare (1) the rates of change of average RNFL-GCIPL thickness (primary outcome measure), and (2) the rates of change of VF mean deviation (MD) (secondary outcome measure) between treatment groups. We hypothesize that patients treated with metformin have a slower rate of RNFL-GCIPL thinning, and a slower rate of VF MD decline compared with those treated with placebo at similar levels of IOP over the 24-month follow-up. The proposed study has the potential to mark a paradigm shift in the management of glaucoma patients by demonstrating that neuroprotection is attainable with metformin, which will alleviate the increasing burden of glaucoma blindness in China and other Asian countries where glaucoma patients with normal levels of IOP are prevalent. Furthermore, it will inform and impact the study design in future neuroprotection trials which can expedite the development of neuroprotective therapy for glaucoma.

NCT ID: NCT05366647 Not yet recruiting - Clinical trials for Glaucoma, Open-Angle

GATT Versus Canaloplasty (GVC)

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Study aims to compare the effectiveness and safety profile of Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Gonioscopy-assisted Transluminal Trabeculotomy is the procedure that aims the same mechanism of aqueous outflow, however is perform with ab interno approach, which comprise it to the minimally invasive glaucoma surgery techniques. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication burden and complications rate. So far there is no comparison of the Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty available.

NCT ID: NCT05352854 Not yet recruiting - Glaucoma Clinical Trials

Morphological Changes of Ciliary Body and Trabecular Meshwork

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Glaucoma is the leading cause of irreversible blindness worldwide. Although the pathogenesis remains unclear, pathologic increase in intraocular pressure (IOP) due to blocked aqueous outflow through the trabecular-Schlemm canal is known to be an important risk factor, and reduction of IOP is the only clinically validated way to retard the progression of OAG. Ciliary muscle plays a central role in the trabecular meshwork-Schlemm canal outflow pathway. Clinical evidence suggests that ciliary muscle contraction stimulated by cholinergic receptor agonist and retraction of ciliary body position after cataract surgery can dilate the lumen of Schlemm canal and reduce IOP. Currently, Ultrasound biomicroscopy (UBM) can obtain two-dimensional images of the anterior segment using high-frequency Ultrasound transducers in medical imaging studies of the ciliary body - trabecular meshwork -Schlemm canal complex. UBM has better tissue penetration than Optical coherence tomography (OCT) and can image the ciliary body better, but it has a lower resolution (30um to 50um) and is poor at imaging tiny tissues such as trabecular meshwork and Schlemm canal. The latest swept-source OCT (SS-OCT) has faster image capture rate (1000000 A scans/SEC), stronger penetration and higher resolution (8um axial resolution and 20um transverse resolution). The structure and morphology of ciliary body-trabecular meshwork-Schlemm canal complex can be clearly photographed. The investigators intend to use CASIA2 to image the ciliary body-trabecular meshwork-Schlemm canal complex before and after administration of pilocarpine in healthy individuals and patients with glaucoma to assess the effect of pilocarpine on the anatomy of the ciliary body-trabecular meshwork-Schlemm canal complex.