View clinical trials related to Cataract.
Filter by:The EYESTAR 900 with software version i9.5.1.0 includes new analysis functionality. Since its clinical performance cannot be assessed based solely on clinical literature as found in the Clinical Evaluation Report, further data from a clinical trial is required. The objective of this trial is to assess the clinical performance of the new features of the EYESTAR 900 with software version i9.5.1.0. This study is a necessary part of the clinical evaluation process of the investigational device. The results of this study are used for the clinical evaluation, and for reporting of in-vivo repeatabilities in the instructions for use of the investigational device, as required by topography standards.
Brief Summary: Age-related cataract is the main cause of impaired vision in the elderly population worldwide. In the UK, more than half of people who are over 65 years old have some cataract development in one or both eyes. The only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted. It is estimated that around 10 million cataract operations are performed around the world each year. Cataract operations are generally very successful, with a low risk of serious complications. During the past two decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient. Traditional spherical monofocal intraocular lenses (IOLs) restore best-corrected vision and may lessen the need for spectacles. These IOLs correct only the spherical portion of the total refractive error and do not correct corneal astigmatism. Astigmatism is a visually disabling refractive error affecting the general population, especially those with cataract. At least 15% to 20% of cataract patients have 1.5 diopters (D) or more of corneal or refractive astigmatism. With increased patient expectations, the trend is not only to remove the cataract but also to address the problem of pre-existing astigmatism at the time of surgery. Surgical-induced astigmatism can be reduced by smaller incisions, i.e. microincision cataract surgery (MICS), which by definition is surgery performed through incisions smaller than 2.0 mm, reducing the need for suturing. This results in better corneal optical quality, thus improving visual outcomes. There are also other surgical options to correct preexisting astigmatism during cataract surgery like: selectively positioning of the phacoemulsification incision; astigmatic keratotomy with corneal or limbal relaxing incisions; excimer laser refractive procedures such as photorefractive keratectomy, laser in situ keratomileusis, and laser-assisted subepithelial keratectomy; or implanting pseudophakic toric posterior chamber intraocular lenses (IOLs). Toric IOLs have been shown to result in good visual and refractive outcomes. Combined with MICS, these IOLs can allow effective correction of cylindrical errors intraoperatively, improving visual quality and thus leading to spectacle independence. Plate haptic and loop haptic toric IOLs have been considered for about a decade but have been associated with postoperative rotational instability. Rotation of a toric lens from its intended orientation degrades its corrective power, with approximately 3.3% loss of cylindrical power for every degree off axis. A misorientation of approximately 30° negates the effectiveness of astigmatic correction, and a misorientation of more than 30° may induce additional astigmatism. Although some patients are asymptomatic despite induced astigmatism, others experience symptoms such as blurred or distorted vision, headache, fatigue, eyestrain, squinting, or eye discomfort. Thus, IOL orientation stability is an essential goal in toric IOL design. RATIONALE The purpose of this study is to assess and compare the axial IOL rotation and optical quality (refraction, visual acuity, decentration and tilt) and capsular bag reaction after micro-incision surgery with an IOL implantation in cataract patients - Acrysof SN60WF, Tecnis ZCB00 & Envista MX60 IOL
The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
This study aims to compare the time required for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.
Effect of phacoemulsification on intraocular pressure has been studied with variable results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior chamber depth and angle opening distance has also been studied. In our study we aim at establishing a quantitative relationship between preoperative ocular biometrics and postoperative intraocular pressure change and comparing this relationship in glaucomatous and non-glaucomatous eyes.
Since recently a second swept-source optical coherence tomography (ss-OCT) optical biometry device was launched (Anterion, Heidelberg Engineering). Aim of this study is a retrospective data collection of patients who were measured with both ss-OCT optical biometry devices and to assess the limits of agreement of the two devices. Retrospective comparison of two ss-OCT biometry devices concerning comparability of measurements of axial eye length, anterior chamber depth, lens thickness and keratometry.
This study is a prospective, open-label clinical study of the VERITAS Vision System. The study will be conducted at up to three sites, with minimum 55 eyes and up to 150 eyes to be treated. The investigator or designee will perform the cataract surgery with the VERITAS Vision System on the subjects. The data from the system log files, the questionnaire, the operative report and other medical records will be used to assess the clinical utilization of the VERITAS Vision System.
In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.
Assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire. Strategic aim: formulation of algorithm and modification of perioperative approach to patient qualified to undergo phacoemulsification procedure.
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.