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Cataract Extraction clinical trials

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NCT ID: NCT05571683 Completed - Anesthesia, Local Clinical Trials

Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection

Start date: June 6, 2022
Phase:
Study type: Observational

Today, phacoemulsification has become the most commonly applied method in the treatment of cataract, which is considered as a public health problem. Since the eyelid margins can be a source for pathogens in phacoemulsification surgery draping after skin sterilization is applied to remove the eyelashes from the operation area. Since surgical drapes are airtight, carbon dioxide (CO2) accumulation occurs under the drape in patients under local anesthesia. During the operation, if the end tidal CO2 pressure value rises, this can lead to hyperventilation and tachycardia and also increase the intraocular pressure which is undesirable in eye surgery. In our study, in order to observe and compare undesirable conditions, regional tissue oxygenation saturation (rSO2) will be determined non-invasively with Transcutaneous Near Infrared Spectroscopy (NIRS) technology , which allows real-time monitoring. Changes in the partial pressure of carbon dioxide (PaCO2) are strongly vaso-active, resulting in changes in cerebral blood volume and hence intracranial pressure. As the optic nerve sheath is an extension of the brain dura mater, the diameter of the sheath expands in case of increased intracranial pressure. Evaluation of the optic nerve sheath with ultrasound allows us to obtain information about intracranial pressure. For optic nerve sheath diameter, measurements above 5.0 mm in adult patients are generally considered as increased intracranial pressure. COVID-19 is a global epidemic caused by SARS-CoV-2 that we are still fighting. Although it is a multisystemic disease, it is important in terms of its effects on pulmonary function and the continuity of pulmonary symptoms and findings after this disease has been overcome. In our study, End-Tidal CO2 and cerebral oximetry (NIRS) values will be determined and compared between the groups that received 2lt/min and 4lt/min nasal oxygen support during cataract surgery performed using draping under local anesthesia in patients who had COVID-19, recovered and never had. It was aimed to evaluate and compare the values of optic nerve sheath diameter increase.

NCT ID: NCT04977115 Not yet recruiting - Cataract Extraction Clinical Trials

Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality of patients.

NCT ID: NCT04977102 Not yet recruiting - Cataract Extraction Clinical Trials

A Randomized Study of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract Patients With Corneal Limbus Opacity

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

The purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and Verion navigation system in phacoemulsification surgery and postoperative visual quality for age-related cataract patients with corneal limbus opacity.

NCT ID: NCT03944070 Recruiting - Clinical trials for Wet Macular Degeneration

Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery

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

To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

NCT ID: NCT03828500 Not yet recruiting - Fasting Clinical Trials

Preoperative Fasting for Ambulatory Cataract Surgery: The PRACTICE Study

PRACTICE
Start date: January 31, 2019
Phase: N/A
Study type: Interventional

The current standard for cataract surgery is phacoemulsification with intraocular lens (IOL) implantation. In this procedure, topical anesthesia has become favoured over local anesthetic blocks due to potential serious complications resulting from retrobulbar or peribulbar anesthesia. Routinely, intravenous sedation is used to supplement the topical anesthesia. If patients are not fasted, there is the potential to reduce preoperative discomfort and anxiety, ultimately improving the satisfaction with the care received. An additional benefit is that liberal fasting policies allow for flexibility in the scheduling of cases, particularly for urgent or semi-urgent situations. Clinical practice guidelines for cataract surgery published by the Canadian Ophthalmological Society (COS) recommend that fasting is unnecessary if only topical anesthesia is used without intravenous (IV) opiates or sedation. In general, these suggestions are in agreement with guidelines from the United Kingdom's Royal College of Ophthalmologists, who note that "it is unnecessary to fast patients for local anesthetic cataract surgery." According to the CAS practice guidelines, the same fasting restrictions are applied when IV sedation or anesthesia with peripheral nerve blocks (e.g. retrobulbar or peribulbar blocks) are administered. At our centre at the Kensington Eye Institute (KEI) in Toronto, Canada, almost all cataract patients receive fentanyl and midazolam, with propofol given only in rare circumstances with close observation. This research project at the Kensington Eye Institute will consist of two phases, namely a prospective, consecutive observational analysis and a prospective time-interrupted study. In the first phase, an observational analysis will be conducted in which consecutive cataract surgery patients will be surveyed with a validated questionnaire to assess their satisfaction. Inclusion criteria will include any cataract patient scheduled for surgery who is willing and able to participate in the study, with fully informed consent provided. Previously published literature has evaluated the use of a patient satisfaction questionnaire regarding preoperative fasting, which includes items on hunger, thirst, hoarseness of voice, difficulty breathing, pain, agitation, anxiety, nausea, vomiting, shivering and problems with concentration. A Research Assistant will complete the questionnaire with all patients preoperatively at KEI, as well as a baseline demographic checklist that will include the patient's age, gender, laterality, surgeon, length of time fasted for solids and clear liquids, as well as the type and amount of solids and liquids. Secondary endpoints will be collected postoperatively and will include the incidence of aspiration, nausea and vomiting, as well as the rate of cancellations of surgeries directly related to issues with fasting guidelines. The first phase of the study will be used to conduct an appropriate sample size calculation, which will ensure that our second phase is not underpowered for the primary efficacy endpoint. In the second phase, a time-interrupted prospective study will be established with the following two arms: (1) experimental arm: patients will be encouraged by the Research Assistant to drink clear fluids right up to the 2 hour limit as specified in the latest ASA and CAS guidelines, with no intervention applied for solids, and (2): control arm: standard of care without any encouragement to drink clear fluids up to the 2 hour limit. Patients will be assigned to groups based on month, so that the first month of study execution will enroll all patients into the experimental arm, the second month will enroll only into the control arm, and that subsequent months will alternate enrollment in a similar method. Given the design, the study will be in accordance with the latest ASA and CAS preoperative fasting guidelines, and will not involve any use of financial or other methods of coercion to incentivize patients that are randomly assigned to the experimental arm. The encouragement process will only involve the Research Assistant asking and encouraging the patient to drink a standardized quantity of clear fluid (up to 400mL of water, coffee, tea, apple or cranberry juice and maximum of 2 teaspoons of sugar) up to the ASA and CAS mandated guideline of 2 hours preoperatively, with the patient making the final determination of whether to comply. Following the encouragement process, a demographics and satisfaction questionnaire will be administered to each patient preoperatively, as well as another satisfaction questionnaire administered following the surgery. Baseline demographics, primary and secondary endpoints will remain consistent with the first phase.

NCT ID: NCT03364972 Completed - Clinical trials for Patient Satisfaction

A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00

Start date: February 6, 2018
Phase: N/A
Study type: Interventional

This is a bilateral randomised controlled study to compare visual performance, refractive outcome, forward light scatter, patient satisfaction and objective measurement of glistenings following insertion of two monofocal, aspheric, hydrophobic acrylic intraocular lenses (IOLs). A new product is compared with an established one.

NCT ID: NCT02973880 Completed - Cataract Clinical Trials

Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction

Start date: October 15, 2017
Phase: Phase 3
Study type: Interventional

Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success. Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation. After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative. NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time. The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.

NCT ID: NCT02332369 Recruiting - Cataract Extraction Clinical Trials

EyeKon Medical Inc. Capsular Tension Ring Study

CTR
Start date: February 2005
Phase: N/A
Study type: Interventional

This study evaluates the safety and effectiveness of a capsular tension ring (CTR) when used during cataract surgery. Capsular Tension Rings are used during intraocular lens implantation to give added support in order to keep the intraocular lens well centered, especially in eyes with weak or partially absent zonules. In many cases, capsular tension rings allow a lens to be successfully implanted into an eye which otherwise could not have supported an intraocular lens.

NCT ID: NCT01198483 Recruiting - Cataract Extraction Clinical Trials

Microincision Versus Smallincision Combined Surgery

Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to compare refractive outcomes after two different types of combined cataract surgery, namely microinscision cataract surgery and smallincision cataract surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal disorders and coexisting cataracts.

NCT ID: NCT00924729 Completed - Cataract Extraction Clinical Trials

Study of Ocular Penetration of Topically Administered Fluoroquinolones

Start date: September 2009
Phase: Phase 4
Study type: Interventional

This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.