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Cataract clinical trials

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NCT ID: NCT05811182 Completed - Clinical trials for Cystoid Macular Edema Following Cataract Surgery

Vitreous Hyper Reflective Dots in Association With Pseudophakic Cystoid Macular Edema

Start date: July 1, 2018
Phase:
Study type: Observational

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.

NCT ID: NCT05790993 Completed - Cataract Senile Clinical Trials

Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)

Start date: June 20, 2022
Phase:
Study type: Observational

Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. In order to allow cataract extraction and IOL insertion, during the surgery a small incision is performed by the surgeon. This incision is performed using surgical knives, and a smaller incisión is associated with less postoperatory inflammation, faster corneal wound healing, and faster visual recovery. Several studies reported the importance of smaller incisions to reduce the risk of surgically induced astigmatism. In order to implant the IOL through this small incision, the IOL must be preloaded in a injector that allows introducing the IOL eficiently and consistently. The manual injector BIOLI manufactured by AST Products (model D), CE approved, is designed specifically to allow the IOL insertion safely, precisely, and controllably. Among the main characteristics of this delivery system is its design to minimize the incision size widening while inserting the IOL. The present retrospective study aims to provide more information with regards to the clinical efficacy of the BIOLI-D delivery system for the implantation of the trifocal Asqelio TFLIO130C IOL in patients submitted to cataract surgery. This will be assessed by analyzing the change in incision size after IOL implantation and the incidence of adverse events during and after the procedure.

NCT ID: NCT05783583 Completed - Cataract Clinical Trials

A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) and a Predicate Device.

Start date: October 1, 2022
Phase:
Study type: Observational

A clinical study has been identified as a requirement for the RDSL (Theia). This study involves a clinical comparison of the imaging from the RDSL with that of a predicate device. The clinical evaluation showed that there remains some residual risk in the practitioner's ability to use the imaging from the RDSL to detect pathologies at the same level as when using the imaging function on a predicate device. The aim of this comparative study is to determine the degree, if any, of difference in using images captured from the RDSL for clinical inspection of pathologies, when compared to images captured from a predicate device. Due to the involvement of real patients during the study, ethics approval was sought prior to commencement. This study is limited to the clinical benefits of the device. An additional Human factors study has been conducted to assess the useability of the device Images were taken of healthy eyes and eyes with pathology (with images of several pathologies from each major pathology group to give a full range) on both the predicate device, and the RDSL.

NCT ID: NCT05782452 Completed - Congenital Cataract Clinical Trials

Genetic Diagnosis in Congenital Cataracts

Start date: January 1, 2021
Phase:
Study type: Observational

The prediction of genetic risk in congenital cataract patients has great clinical significance. In this trial, the investigators aim to screen the causative variants from 115 unrelated bilateral congenital cataract patients enrolled consecutively, describe novel and recurrent variants, analyze the factors affecting genetic diagnostic yield, and explore potential phenotype-genotype correlation.

NCT ID: NCT05779306 Completed - Clinical trials for Cataract Complicated

Performance of Two Sclera Fixated Intraocular Lens Concepts

Carlevale
Start date: January 19, 2023
Phase:
Study type: Observational

To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).

NCT ID: NCT05776446 Completed - Cataract Clinical Trials

Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Start date: May 27, 2022
Phase:
Study type: Observational

The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation

NCT ID: NCT05765201 Completed - Nuclear Cataract Clinical Trials

Phacoemulsification at High IOP and Physiologic IOP: Impact on Anterior and Posterior Segment Physiology

Start date: September 22, 2022
Phase:
Study type: Observational

The purpose of this study is to investigate the anterior and posterior structure and functional changes and vascular alterations when performing phacoemulsification at high IOP vs low, more physiological IOP using Centurion® Vision System with Active Sentry® handpiece. These devices are approved by the US Food and Drug Administration (FDA).

NCT ID: NCT05758883 Completed - Cataract Clinical Trials

Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)

Start date: January 12, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).

NCT ID: NCT05750225 Completed - Cataract Clinical Trials

Clinical Investigation of the Safety and Performance of Model 690AD and Model 690ADY Monofocal Intraocular Lens Implantation

Start date: February 2, 2023
Phase:
Study type: Observational

Medicontur hydrophilic posterior chamber monofocal intraocular lens (IOLs) are indicated to improve vision at far distance in adults with cataract and/or ametropia (hyperopia, myopia), secondarily to removal of the crystalline lens. The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power. The study will be performed partially as a retrospective study with patients enrolled who had been implanted with 690AD or 690ADY IOLs mono- or binocularly between September 2021 - March 2022. Data from five visits will be collected: - Baseline preoperative (maximum 90 days prior to surgery)- retrospective - IOL implantation Day 0 - retrospective - Postoperative visit at Day 1 (+/- 0 days) - retrospective - Postoperative visit at 1 month (+/- 2 weeks) - retrospective - Postoperative visit at 12 months (+/- 3 months) - consent and prospective visit

NCT ID: NCT05748275 Completed - Cataract Clinical Trials

Randomized Trial Comparing Prediction Accuracy of Two Swept Source Optical Coherence Tomography Biometers

Start date: July 19, 2021
Phase:
Study type: Observational

To assess if the Alcon Argos Biometer utilizing the Barrett Universal II formula for IOL calculations can give a non-inferior outcome when compared to the Zeiss IOL master 700 utilizing the (PCA) with the Barrett Universal II (TK) formula, when comparing the (mean absolute prediction error of the predicted target spherical equivalencies).