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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: 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: 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: NCT06345820 Recruiting - Cataract Clinical Trials

Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses

Start date: June 28, 2023
Phase: N/A
Study type: Interventional

Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.

NCT ID: NCT06327347 Recruiting - Cataract Clinical Trials

Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg

C2H
Start date: July 17, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator. This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint. The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent. Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.

NCT ID: NCT06325397 Recruiting - Nuclear Cataract Clinical Trials

Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP)

Start date: October 23, 2023
Phase:
Study type: Observational

To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication

NCT ID: NCT06323915 Recruiting - Cataract Clinical Trials

Comparative Study of 3 Multifocal Intraocular Lenses in Murcia

C3M
Start date: April 20, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the performance of 3 intraocular lenses (IOLs): FineVision (comparator), ARTIS SYMBIOSE (study lenses), and Tecnis Synergy (comparator) through binocular distance-corrected defocus curve. This main objective will be to show superiority of the ARTIS SYMBIOSE system through binocular distance-corrected defocus curve. The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent. Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits.

NCT ID: NCT06298890 Recruiting - Cataract Clinical Trials

The Pattern of Dry Eye Disease After Cataract Surgery

Start date: March 2024
Phase:
Study type: Observational

This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.

NCT ID: NCT06294795 Recruiting - Astigmatism Clinical Trials

Toric Intraocular Lens Implantation in Pediatric Cataract

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

To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism