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Glaucoma clinical trials

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NCT ID: NCT05973305 Completed - Clinical trials for Primary Open Angle Glaucoma of Both Eyes

Comparative Study of Dorzol Eye Drops, 20 mg/ml Versus Trusopt® Eye Drops, 20 mg/ml

Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The goal of this study is to compare efficacy and safety of Dorzol 20 mg/mL Eye Drops manufactured by JADRAN-GALENSKI LABORATORIJ d.d. (Croatia) aimed at lowering elevated IOP in patients with ocular hypertension and primary open-angle glaucoma (POAG) versus TRUSOPT 20 MG/ML Eye Drops manufactured by Laboratoires Merck Sharp & Dohme-Chibret, France. The main questions it aims to answer are: - if the efficacy of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal; - if the safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal. A total of 118 participants were screened and randomized 1:1 to the investigational drug (Dorzol) group or the reference drug (Trusopt) group. 59 patients were recruited in each group. Researchers compared the investigational drug (Dorzol) group with the reference drug (Trusopt) group to see if the efficacy and safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma are equal.

NCT ID: NCT05968547 Not yet recruiting - Glaucoma Clinical Trials

Evaluation of Patients' Requirements for Improved Advice and Guidance on Vision Standards for Driving in Glaucoma

D&G
Start date: August 25, 2023
Phase:
Study type: Observational

Glaucoma can affect both central and peripheral vision. Clinicians need to discuss with patients the vision related driving standards and any specific limitations their patients may have relating to their ability to drive with glaucoma. According to the recent guidelines by the General Optical Council (GOC), clinicians are advised to make sure that the Driving and Vehicle Licensing Agency (DVLA) is informed about patients who do not meet the driving vision standards. There are several limitations in making a professional judgement about a patient's suitability to drive and in providing appropriate advice to patients. The main concern is discussing this sensitive issue with the patient based upon available clinical evidence e.g. vision or visual field and directing them to inform the DVLA of their condition or potentially advising them to stop driving. The purpose of this research is to investigate the two main issues 1. To explore patients' understanding of standards of vision for driving. 2. Comparing the standards of vision for driving estimated in the clinic with number plate vision. We propose to do a mixed methods analysis using a patient survey and quantitative investigation of driving vision standards.

NCT ID: NCT05964634 Not yet recruiting - Myopia Clinical Trials

Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia

Start date: August 1, 2023
Phase:
Study type: Observational

This study intends to analyze the characteristics between peripapillary retinal nerve fiber layer thickness and peripapillary area in high myopia with or without glaucoma

NCT ID: NCT05960513 Not yet recruiting - Depression Clinical Trials

Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients

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

Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe glaucoma-induced visual impairment and blindness, respectively.1 However, these figures are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression.2 The relaxation response evoked by mind-body interventions, such as breathing exercises and meditation, is known to reduce stress and improve quality of life (QOL). In a recent study, mindfulness-based meditation was found to reduce intraocular pressure and improve QOL in patients with glaucoma.3 A feasibility study will be conducted using a mixed-method design to assess the feasibility of the online delivery of an intervention titled Breathing Exercises followed by Meditation for potentially enhancing the QOL and mental health of glaucoma patients. Upon recruitment, participants will undergo blocked randomization to either the intervention arm or usual care arm, stratified by sex. Participants in each arm will complete online questionnaires at baseline and after 12 weeks to collect data on health-related quality of life (HRQOL), depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI). Our study can help to assess the feasibility of conducting a pilot study on breathing exercises followed by meditation to assess its effects in a sample of patients with glaucoma.

NCT ID: NCT05954637 Recruiting - Glaucoma Clinical Trials

Correlation of Structure and Function in Glaucoma

Start date: July 1, 2023
Phase:
Study type: Observational

The aim of the study is to correlate structure and function in patients with glaucoma. To this end, a cross-sectional study unsing perimetry and optical coherence tomography is performed.

NCT ID: NCT05943184 Completed - Congenital Glaucoma Clinical Trials

Cognitive Behavioral Nursing Model

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Materials and Methods 1. General information This study enrolled 153 patients with congenital glaucoma who were treated at our hospital from January 2021 to December 2022. These patients were divided into an observation group (n = 76) and a control group (n = 77) using a random number table. The inclusion criteria were as follows: (1) meeting the diagnostic criteria for glaucoma, (2) following the attending doctor's recommendations to receive surgical treatment, and (3) volunteering to participate in the study. The exclusion criteria were as follows: (1) severe organic dysfunction, (2) cardiovascular and/or cerebrovascular diseases, (3) hypertension, (4) contraindications for surgery, (5) other eye diseases, (6) communication disorders, and (7) mental illnesses. Informed consent with signature was obtained from every participant, and the study has been approved by the hospital's ethics committee. 2. Research methods The control group was provided with routine care, including warm reception and provision of a quiet, clean, and well-ventilated ward environment for good rest. Patients were educated to broaden their knowledge of the disease and related surgical treatment, particularly the importance and outcomes of surgical treatment, thereby allaying their feeling of fear and boosting their confidence in recovery. Meanwhile, patients were encouraged to break their unhealthy habits, avoid bad diet choices, and take medications on time. The observation group received CBNI described as follows: (1) A cognitive-behavioral intervention group was set up by several nurses who had a background of systematic cognitive intervention training, were able to independently develop comprehensive behavioral intervention plans and assess a patient's cognitive level, and had an adequate understanding of the fundamentals of cognitive behavioral intervention. Through thorough communication with patients, these nurses were supposed to identify their major concerns and assess their cognitive behavior. Based on the assessment results, psychological counseling was provided for every patient, with each session lasting at least 50 minutes. In addition, the nurses were required to reassure all patients by proactively introducing the precautions of surgery and nursing care. (2) Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. Professional education was provided through communication with patients so that they could gain detailed knowledge of the disease. Chatting and music were useful to relieve tension and psychological stress. Regular patient support groups were organized to help patients develop confidence and a positive attitude toward the disease. (3) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. The nurses were also required to closely monitor patient compliance from the perspectives of diet, lifestyle, psychology, and treatment. (4) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. It should be noted that smooth bowel movements are essential to prevent increased IOP induced by constipation. Therefore, the recommended diet is high in dietary fiber and fruits. (5) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans. The nurses were responsible for guiding the proper use of eye drops by patients, reminding all patients to seek medical attention immediately if they experienced any eye discomfort, and stressing the risk of increasing IOP due to prolonged periods of looking down and other unhealthy habits. 3. Statistical analysis The software SPSS22.0 was used for data analysis. Measurement data were expressed as "mean ± standard deviation (x±s)", and comparisons between the two groups were examined by the t-test. Enumeration data were represented as percentages (%) and inter-group comparisons were examined using the χ2 test. Significance was set at the level of P <0.05.

NCT ID: NCT05940623 Not yet recruiting - Glaucoma Clinical Trials

Impact of Home Intraocular Pressure Telemonitoring on Intraocular Pressure Control and Glaucoma Progression

Start date: August 24, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to conduct a study randomizing glaucoma patients to home intra-ocular pressure (IOP) telemonitoring combined with Smart phone-based intervention (Management Paradigm I) or Smart phone-based intervention alone (Management Paradigm II), with the objectives to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal nerve fiber layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. We hypothesize that glaucoma patients randomized to Management Paradigm I will (1) attain lower levels of intra-ocular pressure (IOP), and (2) a slower rate of Retinal nerve fiber layer (RNFL) and ganglion cell inner plexiform layer (GCIPL) thinning compared with those randomized to Management Paradigm II because of having a more precise assessment of intra-ocular pressure (IOP) to guide intra-ocular pressure (IOP)- lowering therapy would be feasible in Management Paradigm I. It aims to: to compare (1) Goldmann applanation tonometry (GAT) intra-ocular pressure (IOP) measurements over the entire study period (primary outcome measure) and (2) the rates of Retinal Nerve Fiber Layer (RNFL) thinning (secondary outcome measure) between the two Management Paradigms. Participants will asked to do, - Management Paradigm I: will be provided with an iCare Home and instructed to measure and upload 6 intra-ocular pressure (IOP) measurements weekly (2 days a week, 1 measurement in the early morning (5 am to 9 am), 1 during the mid-day (12 pm to 4 pm) and 1 in the evening (7 pm to 11pm)) to a secure server via iCare CLINIC (the number of weekly intra-ocular pressure (IOP) measurements follows the number of weekly blood pressure measurements in the HyperLink study). The morning measurement will include two readings with the first obtained in the supine position before getting out of the bed and the second obtained in the upright position right after. Patients may take additional intra-ocular pressure (IOP) measurements in supine position if they wake up in bed from sleep, as well as other times of the day, but this is not mandatory. These additional intra-ocular pressure (IOP) measurements will not be included for treatment decisions during the study period. - Management paradigm II: Patients will be treated with a topical prostaglandin analogue after baseline intra-ocular pressure (IOP) measurements.

NCT ID: NCT05938699 Recruiting - Open Angle Glaucoma Clinical Trials

Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution

Whistler
Start date: December 12, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a double-masked, placebo-controlled study which will determine the action of NCX 470 ophthalmic solution, 0.1% on aqueous humor dynamic parameters in healthy volunteers or subjects with OHT.

NCT ID: NCT05932940 Active, not recruiting - Angle Glaucoma Open Clinical Trials

Incidence of Descemet Membrane Detachment Post GATT by AS OCT

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

detection of Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.

NCT ID: NCT05925894 Completed - Cataract Surgery Clinical Trials

Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.

MIGA
Start date: March 18, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to compare Mydrane ®, mydriatic eye drops and Mydriasert ® in terms of pupil site stability, surgical time, visual field and anterior chamber configuration modifications among primary open angle glaucoma (POAG) patients during cataract extraction surgery.