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Cataract clinical trials

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NCT ID: NCT06383273 Recruiting - Cataract Clinical Trials

A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR)

Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement (CELR). It will also learn about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike substance that contains no drug) to see if MELT-300 works on procedural sedation in adult participants undergoing CELR. Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product. The main questions it aims to answer are: 1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery? 2. To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation (to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300) 3. To determine the time to achieve preoperative target sedation level with MELT-300 4. What medical problems do participants have when taking MELT-300 vs placebo Eligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to 1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine) 2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam) 3. Placebo (i.e. 1 matching placebo sublingual tablet) Participants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel [i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)]. The effectiveness of MELT-300 will be performed after study medication is administered before surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication.

NCT ID: NCT06380478 Recruiting - Cataract Clinical Trials

Safety and Efficacy of the Bi-Aspheric Monofocal IOL

Start date: March 5, 2024
Phase:
Study type: Observational

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.

NCT ID: NCT06379477 Not yet recruiting - Refractive Errors Clinical Trials

Correction of Refractive Error Surprises After Cataract Surgery in Adults

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery.

NCT ID: NCT06377514 Recruiting - Cataracts Clinical Trials

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

NCT ID: NCT06377007 Recruiting - Cataract Clinical Trials

Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION)

ORION
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Cataract surgery represents a common surgical intervention, encompassing the extraction of the opaque natural crystalline lens, followed by the substitution with an artificial intraocular lens (IOL). To ascertain an IOL possessing optimal power, antecedent to the surgery, preoperative evaluations are conducted through the utilization of a biometric devices. Diverse categories of these instruments are accessible, each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power. The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry.

NCT ID: NCT06365762 Completed - Clinical trials for Age Related Cataracts

The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract

Start date: January 1, 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The study objectives were: - To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity; - To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and - To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s).

NCT ID: NCT06364761 Not yet recruiting - Cataract Clinical Trials

Assesment of Intermediate Vision After BIL Cataract Surgery

Start date: April 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens". The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery. Participants will: - Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters) - Have to fill in 2 questionnaires about visual functioning and spectacle independance Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .

NCT ID: NCT06358664 Recruiting - Cataract Clinical Trials

Caffeine and Cataract After Pars Plana Vitrectomy

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.

NCT ID: NCT06356324 Completed - Anxiety Clinical Trials

The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery

Start date: October 18, 2021
Phase: N/A
Study type: Interventional

This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events. The key questions that are to be answered are: 1. Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients? 2. Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?

NCT ID: NCT06354296 Not yet recruiting - Cataract Clinical Trials

Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy

Start date: April 15, 2024
Phase:
Study type: Observational

The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) [Holladay 1 (D-K)] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula.