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123 active trials for Cataract

Evaluation of Cataract Surgery Outcome

The purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements.

Start: August 2013

Clinical Investigation of Two Tecnis Investigational Lenses

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL. The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.

Start: June 2021

Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol

The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.

Start: May 2021

PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL

Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

Start: February 2020

IOLMASTER 700 Central Topography Workflow Study.

The use of ocular biometers like IOLMaster 700, is a common practice to identify several ocular parameters such as the keratometry of the cornea and the axial length of the eye, which are necessary for calculating the power of the intraocular lens in cataract surgery. However, the additional use of other devices, such as Cassini and Pentacam is used to obtain more information of the central topography of the eye. Recently, a new version of the IOLMaster 700 equipment that provides much more detailed information than in its previous version has been presented. The objective of this study is to measure the time that the new IOLMaster 700 takes to perform these measurements of the central topography and compare it with the time it takes using the central topography using the standard IOLMaster 700 version with Cassini on one hand and Pentacam on the other. It is hypothesized that the use of the new version of the IOLMaster 700 equipment alone can reduce the time of measurements and improve the clinic workflow.

Start: May 2021

Hypochlorous Acid Disinfection Prior to Cataract Surgery

Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.

Start: October 2020

Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

The purpose of this study is to assess the effects of diabetes mellitus (DM) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (FLACS). Patients with DM routinely undergo FLACS, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. Importantly, DM alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. The results from this study will provide insight into the risks and benefits of FLACS in patients with DM.

Start: May 2021

PMCF Study of Preloaded Trifocal IOL

This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.

Start: June 2021

Comparison Mydriasis by Mydrane With Topical Drop Application

The primary aim of the study is to compare the effectiveness of the intracameral application of Mydrane® (standardized combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1%) with the preoperative topical application (Tropicamide 0.5% and Phenylephrine 10%). To evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.

Start: August 2020

Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial

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.

Start: April 2021

Premium Trifocal IOL Comparative Analysis

Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.

Start: November 2017

Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

Start: October 2017

Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

Start: February 2018

PMCF Study on Monofocal Toric IOL (PODEYE TORIC)

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)

Start: May 2021

PMCF Retrospective Study Outcomes of a Premium Monofocal IOL

Multicentric, retro- / prospective, open-label, observational PMCF study to investigate visual performance, contrast sensitivity and patient satisfaction after mono- or bilateral implantation of Isopure 1.2.3. intraocular lenses following cataract surgery. The study treatment itself is not part of this observational clinical investigation. Only patients that already have been implanted with the device under investigation qualify for this retro- prospective observational clinical study.

Start: May 2021

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

This is a multicentric, 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. PHY2103)

Start: May 2021

Levofloxacin Ocular Implant for Ocular Surgery

This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.

Start: January 2021

Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract

COSMOS-Eye is an ancillary study of the COcoa-Supplement and Multivitamins Outcomes Study (COSMOS; NCT02422745). COSMOS is a randomized clinical trial of cocoa extract supplement (containing a total of 600 mg/d flavanols, including 80 mg (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement reduces the risk of cataract and AMD, two leading causes of visual impairment in US men and women.

Start: June 2015

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

Start: May 2021

Clinical Study to Investigate Visual Performance of a Hydrophobic Monofocal IOL After Bilateral Implantation

Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3 IOL.

Start: May 2018