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Cataract clinical trials

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NCT ID: NCT04122651 Not yet recruiting - Cataract Clinical Trials

Toric Intraocular Lenses for Cataract Patients in the NHS

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

To assess visual performance, refractive outcome, and patient satisfaction with the use of "off the shelf" toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.

NCT ID: NCT03976791 Not yet recruiting - Cataract Clinical Trials

A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision. The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification. Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification. Study Design: A prospective randomized controlled study

NCT ID: NCT03851172 Not yet recruiting - Cataract Clinical Trials

Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

This study aim at determining the efficacy of Nepafenac and Ketorolac in obtaining adequate intraoperative mydriasis and preventing miosis during cataract surgery. It also compare the efficacy of both Nepafenac versus Ketorolac, and determine the more effective agent in preventing miosis during cataract surgery. The investigators try to determine if the effect of preoperative NSAIDs agents use would show a financial benefit, or this manoeuvre would add a financial load on the patients who are candidate for cataract surgery.

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: NCT03766230 Not yet recruiting - Senile Cataract Clinical Trials

Clinical Study on Second-eye Pain in Cataract Surgery

Start date: December 30, 2018
Phase:
Study type: Observational

The degree of perceived pain in the second-eye surgery of cataract patients is significantly higher than that in the first-eye surgery, which can lead to nervous tension during surgery and affect the surgical outcome and satisfaction. Study suggested that in addition to psychological factors, there might be subclinical sympathetic reactions leading to increased pain in the second-eyes, but the objective indicators and clinical relevance are not clear. Therefore, it is necessary to study the mechanism of second-eye pain in cataract surgery, and to provide a test index that can effectively predict the degree of intraoperative pain in patients, as an important reference for the development of a suitable time for second eye surgery. This study is based on clinical case studies, recruiting patients with clinically diagnosed binocular age-related cataract and require binocular surgery, to compare the correlation of intraocular inflammatory factors in the second eye and patients' self-pain scores while both eyes' surgery are completed by the same doctor in the same operating room, and the correlation of the change of inflammatory factors and the time interval between the two eyes surgery, to analyze the second-eye subclinical sympathetic reaction changing with the time interval after the first cataract surgery from the molecular biological results. Using the latest international anterior segment vascularization optical coherence tomography(OCT) scan and optical microvascular imaging(OMAG) analysis technology to quantify iris blood flow, this study analyzes the iris blood flow density, vascular density and other indicators before and after cataract surgery, and carry out its correlation with the degree of intraocular subclinical sympathetic reaction, providing a rapid, non-invasive objective examination index of the second-eye subclinical sympathetic response.

NCT ID: NCT03726606 Not yet recruiting - Cataract Clinical Trials

A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.

NCT ID: NCT03593616 Not yet recruiting - Cataract Clinical Trials

Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery

Start date: September 2018
Phase:
Study type: Observational

Globally, cataract is the major cause of blindness accounting for 51% of total blindness and there are regional variations in it. Today, cataract surgery is a highly successful and cost-effective procedure, which enhances both the vision and quality of life of patients. Visual acuity alone should not be used as a criterion for planning cataract surgery, since visual acuity and function do not necessarily correlate. Therefore, there is a need to review our criteria for management. Based on recent studies, at least 90% of the patients undergoing cataract surgery obtain a postoperative visual acuity of 6/12 or better in the absence of coexisting ocular pathology. A number of previous studies have looked at the effect of risk factors on visual outcomes following cataract surgery. Risk factors commonly associated with worse visual outcomes include: age-related macular degeneration, diabetic retinopathy, corneal opacity/pathology, older age, female sex, previous vitrectomy, previous retinal detachment surgery, alpha-blockers, complex surgery, intraoperative complications and refractive surprise.

NCT ID: NCT03579368 Not yet recruiting - Cataract Clinical Trials

Prospective Evaluation of the Tecnis Symfony Intraocular Lens (IOL)

Start date: July 5, 2018
Phase: N/A
Study type: Interventional

Advances in cataract surgery and premium IOLs have allowed the ophthalmologist and optometrist to embrace the fact, as with Lasik patients, that refractive cataract surgery can allow their patients to be potentially free or less dependent on glasses. However, fewer than 13% of all patients undergoing cataract surgery today choose a premium IOL and of these approximately 5% are presbyopic IOLs. The need for greater optometric involvement in cataract surgery is necessary as demand for cataract surgery increases with the population ageing. According to a recent American Optometric Association survey, optometrists diagnose, on average, 13 cases of cataracts per month and refer or co-manage about half of them that are sent for surgery. Since patients base their decision and selection primarily on doctor recommendations, it is incumbent on the optometric community to be well informed on the benefits of the Advanced Technology IOLs. There is currently no data that has been collected comparing Advanced Technology IOLs and their clinical outcome and acceptance rate among patients co-managed with optometrists. This pilot study will study the subjective visual symptoms, spectacle independence at various distances and patient satisfaction after bilateral implantation of the Tecnis Symfony Extended Range of Vision Advanced Technology IOL in this co-managed care environment. The primary assessment tool will be a Non-directed Patient Satisfaction and Symptoms Questionnaire. Initial questions would include; "How satisfied are you with your spectacle-free vision at distance/intermediate/near?", "Would you choose the same lens again?" and "Would you recommend the same lens to your relatives and friends". Similarly, with regard to Photic phenomena / visual symptoms, we would ask "Do you experience any problems with your vision?" and only follow up with specific questions on severity once the patient volunteers a specific symptom.. The surgery form will include a question determining the surgeon's satisfaction with the individual Symfony lens implantation. At last visit the optometric investigator will be asked about his satisfaction with the performance of the Symfony lens. This will allow monitoring of any progression of satisfaction as more experience with the lens is obtained.

NCT ID: NCT03500809 Not yet recruiting - Clinical trials for Post-Op Complication

Aqueous Release to Treat IOP Spikes Post-cataract Surgery

Start date: August 12, 2018
Phase: N/A
Study type: Interventional

Intraocular pressure (IOP) rise after cataract surgery is an important and common problem. Over 300,000 cataract operations are done per year in the United Kingdom alone. IOP rise can adversely affect vision and can be particularly detrimental in glaucoma patients with pre-existing visual field defects. The aim of this study is to evaluate the efficacy and safety of aqueous humor release (also known as burping of the wound), a procedure that has been used for decades to quickly reduce acute IOP spikes following cataract surgery. Currently there is no published evidence on a standard technique to perform wound burping. Similarly there is uncertainty around the amount and duration of the IOP decrease, and the type and frequency of complications eventually associated. This will be the first research project formally evaluating this procedure. This study will also help allay issues over fluid release in high IOPs and consequences of such dramatic IOP drop which concerns ophthalmologists who do not routinely use this technique.

NCT ID: NCT03244072 Not yet recruiting - Endophthalmitis Clinical Trials

Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

Start date: June 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis