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Cataract clinical trials

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NCT ID: NCT04809402 Active, not recruiting - Cataract Clinical Trials

Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

CORE-RCT
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

Background of the study: Cataract is widely prevalent in especially elderly and cataract extraction surgery has thus become one of the most performedsurgeries worldwide. In recent decades the safety of cataract surgery has greatly improved and it is considered one of the safestsurgeries to be performed. Postoperative management consists of routine examinations within one week, to ascertain no adverseevents have occurred immediately after surgery, and between 4-6 weeks, to determine the refractive error. The incidence of seriousadverse events following cataract surgery is estimated to be 1%. As a result, the majority of patient visits after cataract surgery willbe uneventful. Nonetheless valuable time and hospital resources are consumed. Remote monitoring could replace clinicalexaminations in selected patient groups. However, this practice of digital remote monitoring which the patient can use independentlyhas not been clinically validated yet. Objective of the study: To determine non-inferiority of the corrected distance visual acuity (CDVA) with the prescription obtained through the web-basedmeasurement of refractive error, compared to usual care, in patients who underwent routine cataract surgery. Study design: Observational randomized trial without interventions Study population: Patients eligible for cataract surgery, without visual acuity influencing comorbidities or predisposing complicating factors. Primary study parameters/outcome of the study: costeffectiveness Secundary study parameters/outcome of the study (if applicable): Corrected distance visual acuity at the final post-operative visit, uncorrected distance visual acuity, refractive error(sphere/cylinder/axes), patient reported outcome measurements, adverse events.

NCT ID: NCT04778501 Active, not recruiting - Cataract Clinical Trials

PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia

PHY2102
Start date: September 7, 2021
Phase: N/A
Study type: Interventional

This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2102)

NCT ID: NCT04763785 Active, not recruiting - Cataract Clinical Trials

Development of a Keratoconus Detection Algorithm by Deep Learning Analysis and Its Validation on Eyestar Images

DKDA
Start date: May 11, 2021
Phase:
Study type: Observational

Monocentric clinical study to develop an imaging analysis algorithm for the Eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

NCT ID: NCT04744467 Active, not recruiting - Cataract Clinical Trials

PMCF Study on Monofocal Toric IOL (PODEYE TORIC)

PHY2101
Start date: May 5, 2021
Phase: N/A
Study type: Interventional

This is a single-center, prospective, open-label PMCF study whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (study no. PHY2101, ClinicalTrials.gov ID: not yet assigned)

NCT ID: NCT04668456 Active, not recruiting - Clinical trials for Acute Postoperative Pain

Subtenon and Intravenous Dexmedetomidine Effect on Patients Undergoing Cataract Surgery

Start date: August 15, 2020
Phase: Phase 3
Study type: Interventional

The study designed to compare the effects and the safety of adding dexmedetomidine to local anesthetics and its intravenous administration in subtenon block in patients undergoing cataract surgery.

NCT ID: NCT04631068 Active, not recruiting - Cataract Clinical Trials

Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

MonoeDOF
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens. Primary Objectives: - To evaluate the distance VA of the study IOLs - To evaluate the intermediate VA of the study IOLs - To explore the safety profile with regards to visual disturbances

NCT ID: NCT04574115 Active, not recruiting - Cataract Clinical Trials

Clinical Investigation of Omega Refractive Capsule, Model VI

ORCVI
Start date: February 6, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)

NCT ID: NCT04570579 Active, not recruiting - Cataract Clinical Trials

Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement

Start date: October 14, 2020
Phase:
Study type: Observational

The introduction of presbyopia-correcting intraocular lenses (PC-IOLs) has provided cataract and refractive surgeons the ability to provide patients with a wider range of visual success and spectacle independence post-cataract surgery.Multifocal (MFIOL) IOLs have the ability to provide near and distance vision, and in the case of trifocal IOLs, near, intermediate and distance. Despite the significant technological evolution of MFIOL's, the potential for visual disturbances, such as glare, halos and starbursts still exists-and in much greater frequency compared to their monofocal counterparts. Extended depth of focus (EDOF) IOLs aim to provide patients with a functional range of vision, with a similar visual disturbance profile to a monofocal lens. In this way, this subset of PC-IOL's can offer patients some degree of spectacle independence, with a significantly lower incidence of visual disturbances. The Vivity Extended Vision IOL is the first of its kind to offer Wavefront Stretching technology, providing patients with an excellent extended range of vision from intermediate to distance, as well as some functional near vision. Prior studies have demonstrated very good vision in both bright and dim lighting conditions, as well as a high degree of spectacle independence with the Vivity IOL, as compared to a monofocal IOL. Studies evaluating the ability of the Vivity IOL to provide a significant impact on patient lifestyle (e.g. patient independence from spectacles for most activities with a low rate of visual disturbances) in the United States in a 'real-world' setting have yet to be performed. In addition, influence of pre-and-perioperative variables such as sex, age, prior refractive surgery, IOL formula used, axial length, astigmatism, use of intraoperative aberrometry, femtosecond laser and pupillary expansion devices has yet to be evaluated on the postoperative success of this IOL. This study will be comprised of patients with visually significant cataracts who will undergo cataract extraction with implantation of the spherical and/or toric models of the Vivity Extended Vision (Alcon, Fort Worth TX) intraocular lens. Upon decision of the patient and surgeon to undergo surgery, patients will be offered the option to enroll in this observational study.

NCT ID: NCT04566237 Active, not recruiting - Cataract Clinical Trials

Objective Measurements of the Opacification of the Lens After Vitrectomy

MOCVIT
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years. In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication. The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units. Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group. To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.

NCT ID: NCT04503356 Active, not recruiting - Cataract Clinical Trials

OMNI in Open-angle Glaucoma Treatment

Start date: April 17, 2018
Phase: N/A
Study type: Interventional

This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures. Medication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.