CDL Validation Study
Eyes Dry ChronicChronic Conjunctivitis of Both Eyes9 moreOcular surface photography is significantly limited in standardization and reproducibility. This reduces its applicability for clinical monitoring of acute or chronic disease. The innovative lens and illumination design of the CDL system aims to yield standardized high resolution photographs of the cornea and conjunctiva as required for clinical documentation, posing a significant clinical benefit of health care providers in the field of ophthalmology. Primary objectives: The primary objective of this study is to test the safety and feasibility of the CDL imaging system in a clinical routine setting. This will include the comparison of subjective contrast sensitivity testing post imaging, and the measurement of examination duration per imaging session, and the comparison of image lightness in mesopic versus photopic imaging. Secondary objectives: The secondary objective of this study is to compare the image quality of the device and repeatability of lateral resolution, dynamic range, hue, saturation, lightness, and image position between colour photographs from a state-of the art slit lamp camera and the CDL system. This is a monocentric, prospective, observational study. Patients with ocular surface disease of variable aetiology routinely assigned to ocular surface photography, following informed consent, will be imaged using state-of-the-art colour photography and the CDL imaging system. Pictures of each patient will be taken under several standardized conditions with both methods, subsequently analysed and compared by a Medical Image Processing Specialist.
Evaluation of Performance of New IFIS Sleeve
CataractA silicone sleeve will be used on the hydrodissection needle to avoid that the iris can prolaps through the gap between needle and incision wound.
Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS)
Surgery-ComplicationsCataractThe aim of this project is to reduce the risks of cataract surgery using the EyeSi simulator Axis 1: to model the learning curve of novice residents in Ophthalmology who follow the training program recommended by the "Collège des Ophtalmologistes niversitaires de France" (COUF) in order to help creating a "licence to operate" Axis 2: to evaluate the impact of sleep deprivation on the surgical performance of experienced residents in Ophthalmology
Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery
AromatherapyAnxietyThe purpose of this study is to assess the validity of lavender aromatherapy as a method of anxiolysis prior to a cataract surgery, and to see if this effect will extend intraoperatively to minimize patients' intraoperative medication requirements. The study team plans on enrolling 186 participants. The investigator team hypothesizes that: Participants will have a lower anxiety score after the intervention Participants will require less intraoperative sedation medication compared to participants that did not have the lavender intervention. A decrease in intraoperative medication requirements will lead to a faster discharge time
Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal...
Lens ImplantationIntraocularA cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see. A cataract is treated by removing the cloudy lens and replacing it with an intraocular lens (known as an IOL). The goal of this clinical trial is to determine if the Eyedeal® IOL can be safely implanted in a subject's eye and if it can replace efficiently the natural lens. Subjects will be asked to attend a total of seven visits for this study for a period of 12 months after surgery.
Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900
CataractAphakic Eye1 moreThis is a prospective comparative study that will be conducted at one clinical site in the United States, in which subjects who sign an informed consent form and fulfil all inclusion and exclusion criteria, will have OCT scans obtained using the test and the predicate devices. There will be two main types of analyses performed as part of this study, including 1) a precision analysis, and 2) an agreement analysis. The precision analyses will be conducted utilizing all complete complements of acceptable scans from the test devices and predicate device for each of the 3 configurations. A complete complement of acceptable scans can be defined as subjects having 3 acceptable replicate scans on each of the 3 devices, at each of the 3 configurations. This is also synonymous with 3 scans for each of the 3 configurations on all 3 devices. If subjects have more than 3 acceptable scans per configuration on a device, only the first 3 will be considered for analyses. The agreement analysis will be conducted utilizing the first set of acceptable scans from each instrument for all overlapping measurement types (for all measurement types two or more of the devices have in common) related to performance endpoints.
Quality Assurance Via Telephone Interviews After Cataract Surgery
CataractTo analyse quality assurance after cataract surgery by assessing discomfort and other symptoms via telephone interviews either in the evening of the day of the surgery or 1 day after surgery versus no additional call after surgery.
Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
CataractPresbyopiaThe purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
Evaluation of the Effectiveness of Stress Ball Practice During Cataract Surgery
CataractAnxiety1 moreCataract surgery is one of the most commonly performed and reliable surgeries among eye diseases. While cataract surgeries were performed under general or local anesthesia in previous years, they are now performed topically. Despite providing conscious sedation with agents such as benzodiazepines and opioids before and during surgery, patients experience pain, anxiety, and discomfort during the surgical procedure. One of the non-pharmacological methods used to relieve acute pain during surgical intervention is stress ball. It is also used to reduce pain and anxiety and increase patient comfort. The stress ball suppresses most of the nerves and muscles directly connected to the brain around the wrist and hand, stimulating nerve and muscle activity. This mechanism reduces the release of stress hormones, regulates blood pressure by providing relaxation and relief, and helps reduce anxiety and acute stress. When literature is examined, it is seen that stress ball application is effective on patients' pain, anxiety, and vital signs; however, no randomized controlled study has been found in which stress ball application was performed during cataract surgery. This study was planned to investigate the effect of stress ball application during cataract surgery on patients' anxiety, pain, and vital signs.
Effects of Visual Reconstruction on Brain Function and Structure in Children With Congenital Cataract...
Congenital CataractsChildren have considerable plasticity of the visual system during the formation and maturation of various visual functions at different ages. Congenital cataracts are the leading cause of treatable blindness in children. With the continuous improvement of surgical approaches and surgical techniques, the success rate of congenital cataract surgery has been significantly improved clinically, and the visual function of children has been significantly improved after surgery. However, to date, there has been no experimental study of specific changes in the brain before and after surgery in children with congenital cataracts to explore its relationship with visual reconstruction. We aim to investigate the effects of congenital cataract surgery on the brain function and structure of children through preoperative and postoperative analysis and comparison of brain imaging such as BOLD-fMRI and DTI, and provide new ideas for the clinical treatment and prognostic assessment of this disease.