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Glaucoma Eye clinical trials

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NCT ID: NCT05895617 Completed - Glaucoma Eye Clinical Trials

Assessment of the Occuity PM1 Pachymeter

Start date: January 15, 2023
Phase:
Study type: Observational

To determine whether the Occuity PM1 device is non-inferior in measuring central corneal thickness when compared to ultrasound pachymetry, the Lenstar and the Pentacam. The Investigation aims to assess long-term safety of the Occuity PM1 device when used under the conditions and for the purposes intended, to ensure it will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons. The central corneal thickness measurements taken by the three devices: Occuity PM1, the ultrasound pachymeter and Lenstar. Demonstrating that the Occuity PM1 Pachymeter is not inferior to the LenStar in terms of equivalency to a 95% confidence level using the Bland Altmen equation/approach based on +/-20micron equivalency. The investigators would like to measure the thickness of the cornea, which is the clear window at the front of the eye. A corneal thickness measurement is important for several reasons. The measurement can tell an eye care professional if the cornea is swollen, which may mean the particiapnt have an increase in fluid within the cornea. Also, assessing corneal thickness can help in the diagnosis of glaucoma and the measurement is important if the participant is going to have eye surgery. The instruments that are currently in use are usually very large and quite expensive and therefore not ideal for use as part of routine eye care. Some instruments require contact with the surface of the eye, which may be uncomfortable. Occuity Ltd. is a medical device company based in Reading, which has been investigating this. They have developed a new instrument (called the 'PM1 Pachymeter') for measuring the thickness of the cornea. The instrument shines a harmless low power beam into the eye and then measures the light reflected back from the eye in order to check the thickness of the cornea. The low power beam is not a visible light and so the participant will not be able to see it. s study will assess how closely the eye measurements taken from the new PM1 Pachymeter matches eye measurements taken from two other devices that are currently on the market. The goal is to provide a non-contact, hand-held meter that is fast and easy to use without the need to contact the eye.

NCT ID: NCT05449041 Completed - Cataract Clinical Trials

Bulbicam Validation on Glaucoma- and Cataract Patients

Start date: January 10, 2023
Phase:
Study type: Observational [Patient Registry]

The aim is to investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls (HC). The study population consists of the three subpopulations: 1) Patients suffering from GLA; 2) Patients suffering from CAT and 3) Gender- and age-matched HC without any eye diseases. Bulbicam will be used in the study including six tests and the standard method will be used initially for measurements of "Visual Field" and "Pupil" The study will be performed as a controlled, open, and non-randomized, stratified observational single center study. The stratification factors will be pathology and the degree of disease. Within each of the four strata, healthy matched controls related to gender and age (1:1) will be included. The main variables will be the variables recorded at the six Bulbicam and the supporting variables will be recorded by the Standard (ST) investigation. The central variables related to Glaucoma will be the GAT and iCare pressure, "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen", X- and Y-coordinates and "Pupil diameter in mm". The central variables related to cataract will be "Pupil diameter", "OCT RNFL ", "Seen /unseen "," Time until the given point is recorded as seen", "the light in decibel when the point is seen" and the X- and Y-coordinates. Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Sixteen GLA-patients and 16 CAT-patients equally divided into two substrata will be recruited from the two participating hospitals. For each included patient, one gender- and age-matched HC will be recruited. In total 16 GLA-patients with 16 HC and 16 CAT-patients with 16 HC will be included in the study.

NCT ID: NCT05147610 Completed - Glaucoma Eye Clinical Trials

Precision of the Icare200 for Measuring Intraocular Pressure

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

In adult patients, intraocular pression readings are often taken with an air puff tonometer or goldmann tonometer. The current gold standard for IOP measurement is the Goldmann Applanation Tonometry (GAT). In some patients, measurement of intraocular pressure taken by applanation or by air puff may prove to be impossible for various reasons (obesity, handicap, mental disorder, blindness for Air Puff Tonometry, Anxiety, etc). There are also many other devices that can be used to measure IOP, including those using rebound tonometry like the Icare 200. The rebound tonometer would systematize IOP screening because of its ease of use, provided its measurements are reliable. In this prospective study, investigators will be measuring participant's IOP with Goldmann Applanation Tonometry, Icare 200 Tonometer and Air Puff Tonometry to see if there is an agreement in IOP between the different devices. Investigators will also look if there is a concordance between central corneal thickness and IOP. Moreover, investigators will look if there is a IOP concordance between the 3 different devices for hight BMI people. Indeed, higher body mass index tend to have difficulties with proper positioning at the slit lamp that may lead to inaccurate GAT measurements. Additionally, stress level of the patients with different tonometry devices will be recorded using a visual analog scale.

NCT ID: NCT04648943 Completed - Glaucoma Eye Clinical Trials

The Effect of Trabeculectomy & Ex-PRESS Glaucoma Drainage Implant on the Corneal Biomechanical Properties

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma

NCT ID: NCT04052165 Completed - Glaucoma Eye Clinical Trials

IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

Glaucoma is a group of diseases that damage the eye's optic nerve, result in progressive visual field defect and blindness. The aim of glaucoma management is to reduce IOP, and glaucoma implant surgery is the alternative treatment that can be chosen. The effectiveness of the implant on the end stage glaucoma patients was evaluated by the reduction of intra ocular pressure (IOP) and well formed blebs that were evaluated clinically and by using anterior scanning optical coherence tomography (AS-OCT). The safety of the implant was determined by the regression of the clinical symptoms and there were no severe complications such as implant extrusion. Two patients developed improvement of the visual acuity. This was an unpredictable positive result.

NCT ID: NCT03996200 Completed - Clinical trials for Glaucoma, Open-Angle

MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Start date: July 23, 2019
Phase: N/A
Study type: Interventional

Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.

NCT ID: NCT03797846 Completed - Glaucoma Clinical Trials

Comparison of Fixation Suture Type in Glaucoma Surgery

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The aim of the study is to compare the effectiveness and safety of two types of intraoperative eye fixation: for the superior rectus muscle and traction suture in the peripheral cornea. This is a prospective randomized trial with a 6 month follow-up period, which covers patients with open angle glaucoma qualified for combined glaucoma procedure (phacotrabeculectomy). In I group, the intraoperatively fixation in the peripheral part of the cornea is used, in II group the bridle suture for the superior rectus muscle is performed.

NCT ID: NCT03624361 Completed - Clinical trials for Glaucoma, Open-Angle

MINIject Glaucoma Implant in European Patients

STAR-II
Start date: May 23, 2018
Phase: N/A
Study type: Interventional

The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

NCT ID: NCT03338101 Completed - Glaucoma Eye Clinical Trials

Comparative Study Between Tonometers

Start date: July 1, 2017
Phase: N/A
Study type: Observational

Comparative study between the Goldmann Flattening Tonometer and the Non-Contact Tonometer in patients of a Reference Ophthalmological Hospital

NCT ID: NCT03187418 Completed - Glaucoma Clinical Trials

Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

Start date: June 19, 2017
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the efficacy and safety of the novel form of trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in adults for the treatment of uncontrolled glaucoma.