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Showing 1-20 of 33 trials
NCT07408817
This study is a randomized controlled trial designed to evaluate the effect of structured teleconference-based counseling provided before cataract surgery on patients' anxiety levels and predefined postoperative outcome measures. The study will be conducted between January 31, 2025, and May 31, 2025, at a public hospital located in the Western Black Sea Region. The study population will consist of patients scheduled for cataract surgery. Eligible participants will be assigned to the intervention or control group using a simple random sampling method. Patients in the intervention group will receive structured teleconference-based counseling prior to surgery, while patients in the control group will receive standard preoperative care. Data will be collected using the Patient Information Form, the State-Trait Anxiety Inventory, the Tele-Nursing Evaluation Form, and the Patient Outcome Form. Participants will be followed up by telephone on postoperative days 1, 3, and 7. Statistical analyses of the collected data will be performed using SPSS version 29.0.
NCT07362043
The goal of this observationnal study is to supplement the data collected in the pre-market study and confirm the rate of capsular ruptures due to Rx (reducing its related confidence interval). During cataract surgery, an artificial lens is placed into the capsular bag. The main question this study aims to answer is : Is Rx use associated with a rate of caspular ruptures lower than 2% ? Medical records of participants having cataract surgery with Rx laser as part of their regular medical care will be assessed in order to answer the study objective.
NCT07317661
Patients with cataracts disease need to choose what type of artificial lens will go into their eye prior to surgery date. Some lenses are standard and are usually covered by insurance. Other "premium" lenses have various benefits such as reducing the need for glasses but usually require out-of-pocket costs. The combined busy outpatient clinic and complexity of artificial lens choices in the ever-changing world of cataract surgery tends to lead patients confused about their available lens options. There is an abundance of educational material present in premium lenses, however these are limited by accessibility and are standardized at single educational levels. Therefore in the present study, we want to test whether giving patients a short LLM powered AI-guided explanation from Custom GPT from OpenAI of lens options prior to their consultation with their doctor can improve visit efficiency, physician explanation and patient understanding of lens options. We will compare two groups: standard of care versus standard of care plus AI education. The LLM in this study is intended to provide supplemental information about premium intraocular lens(IOLs) options to study participants, and is no means supposed to replace a health care professional in the diagnosis, cure, treatment, and/or mitigation of disease. Study is analogous to giving a verified health pamphlet to a patient for them to view and learn different IOL options, in other words, facilitating patient understanding of their options. The LLM will be trained by several health care professionals and MD specialists to provide sufficient instructions. Sources will include verified online resources and MD information. The investigators hope to learn if a large language model-based educational tool can improve visit efficiency, physician explanation and patient understanding of intraocular lens options. New knowledge of this study could guide how cataract counseling is delivered in the future and may help clinics spend more time on individualized questions instead of repeating generic information.
NCT07288086
Evaluation of the safety and efficacy of the new Enova® preloaded monofocal intraocular lens and cartridge injector system in cataract surgery
NCT02892825
The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.
NCT07223866
The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.
NCT07178639
The goal of this clinical trial is to learn which of the drugs bromfenac 0.09%, nepafenac 0.3% and diclofenac 0.1% has better efficacy in treatment and prevention of cystoid macular oedema after cataract surgery. The main questions it aims to answer are: Which of the drugs has better efficacy in macular oedema prevention? What medical problems do participants have when taking different drugs? Researchers will compare drugs to each other. Participants will: Take on of the drugs (randomized) as their treatment in preoperative and postoperative period. Visit the clinic after the surgery on the first day, first week, in three weeks and in six weeks. Undergo retina examination with OCT (optical coherence tomography), best vision, and fill in forms considering their quality of life.
NCT04769856
The aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.
NCT07154147
The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.
NCT07055022
Dry eye disease (DED) is a frequent ocular surface disease (OSD) of multifactorial origin, characterised by disruption of tear film homeostasis and associated with ocular discomfort and/or visual disturbance. Cataract surgery, which is one of the most often performed interventions worldwide, can induce or worsen the symptoms of DED. Despite lack of guidelines on DED prophylaxis before cataract surgery in the general population, there is a growing interest in this topic due to the high prevalence of postoperative DED. A recent randomised controlled trial (RCT) with one month follow-up showed that prophylactic low-level light therapy (LLLT) before and after cataract surgery in patients without pre-existing DED significantly improved postoperative tear film stability, as well as reduced ocular discomfort, compared to no prophylaxis. Apart from LLLT, another light-based treatment for DED is intense pulsed light (IPL); the treatments have shown favourable outcomes in the management of DED, both as stand-alone choices or in combination.
NCT02128113
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
NCT03644875
This is a prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etacoat in patients undergoing cataract surgery. The performance is evaluated by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.
NCT06611670
Cataract surgery is a widely performed procedure across the world that helps restore vision in many patients suffering from cataracts. Irrigation is an essential component of the surgery. Fluid is constantly circulated to help regulate temperature as heat is generated with ultrasound energy, to minimize tissue trauma, and to create an intraocular pressure (IOP) sufficient to keep the anterior chamber (AC) stable. In parallel, aspiration brings the components of the cataract closer to the surgical instrument. A balance between irrigation and aspiration during surgery is essential to maintain stability in the AC. However, an ideal flow rate, which influences IOP during surgery, is yet to be determined. Most recent studies with Centurion Active Sentry show that there is similar efficiency between higher and lower IOP settings. Traditionally, high-flow rates have been used in advanced cataracts and are believed to make space in the AC. However, they are known to create fluid turbulence and are associated with risks of tissue damage, including cell loss in one of the cornea's layers. High IOP during surgery has also been shown to cause damage to the optic nerve as well as to the retina. Distorting and stretching the AC during phacoemulsification have also been associated with increased pain experienced by the patient. Comfort can be achieved by lowering pressure levels. Low-flow rates have a better safety profile, reduce IOP and pressure fluctuations while offering equal efficiency, including comparable surgical time. Using central corneal thickness (CCT) as an indicator of corneal trauma, it has been shown that patients that have had surgery with low-flow rates present no change in the CCT postoperatively as opposed to patients in the high-flow rates. As less fluid turbulence is created with low-flow rates, there is decreased risk of fragment contact with the cornea's inner surface, thus reducing cell loss. Alcon Laboratories, Inc. developed Active Fluidics which allows to stabilize intraocular pressure and prevent IOP fluctuations as well as IOP surges during surgery. It is now further equipped with the Active Sentry handpiece which is integrated to the surgical instrument and acts as a sensor to pressure variation. It allows rapid feedback to maintain a stable AC. Our research project aims to assess the outcomes following phacoemulsification done with physiological IOP with the help of the Active Sentry handpiece compared to traditional high IOP levels.
NCT03375996
Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety and results of modern cataract surgery. However, this technique faces to some obstacles: economics in the one hand due to the cost and time spent for the laser procedure before the conventional surgery, and technical in the other hand, especially due to some loss of pupil dilation during the surgery, which is highly important to ensure a perfect procedure. The present study aims at assessing a pharmacological protocol to maintain an accurate pupil dilation all along the surgery in order to improve the whole procedure.
NCT05692167
The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery
NCT04316936
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
NCT05886283
Purpose: The aim of this study was to evaluate corneal endothelial cell density and morphology, central corneal thickness, and best visual acuity using US phacoemulsification or Nanosecond laser technique. Setting: Department of ophthalmology, Nabeul, Tunisia. Design: Prospective cohort study. Methods: The study included eyes with nuclear cataract density grade 1, 2, 3, or 4 according to LOCS III, divided into two groups; Group 1 had conventional US, and group 2 had nanosecond laser. The Endothelial Cell Density (ECD), coefficient of variation (CoV) in cell size, percentage of hexagonal cells, central corneal thickness and best visual acuity were evaluated over 24 months.
NCT05811182
The aim of this study is to assess the association between vitreous hyper-reflective dots (VHD) and the macular thickness changes following uneventful phacoemulsification. In this prospective study the investigators performed optical coherence tomography (OCT) imaging in patients undergoing cataract surgery preoperatively and postoperatively after 1 week, 1 month and 3 months and analyzed the OCTs for VHDs. The investigators then measured the macular thickness in patients with VHDs and without VHDs and correlated the macular thickness with the number of VHDs.
NCT01344252
The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine. Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia. Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis. Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery
NCT05480839
The focus of this study is to assess the differences in patient perceptions of pain undergoing cataract surgery by using the Refractive Laser-Assisted Cataract Surgery (ReLACS) technique compared to the standard Manual Cataract Surgery (MCS) technique using an immediately sequential bilateral approach. This study also aims to further explore difference in patients' perceptions of pain depending on timing of neurolept anesthesia in the ReLACS technique. The importance of this study is appreciated patient perception of pain during ReLACS, which is an emerging technique for cataract surgery and has been sparsely reported on to date. This investigation will include the analysis of various surgical, ocular, medical, and psychosocial metrics of patients undergoing both ReLACS and MCS at Uptown Eye specialist.