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Cataract clinical trials

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NCT ID: NCT04247152 Completed - Cataract Surgery Clinical Trials

Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery

Start date: July 22, 2019
Phase: N/A
Study type: Interventional

Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

NCT ID: NCT04246801 Completed - Cataract Clinical Trials

Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)

CLOSE-1
Start date: June 10, 2020
Phase: Phase 3
Study type: Interventional

Cataract surgery is one of the most common surgical procedures performed worldwide. In fact, in 2017, 3.8 million cataracts procedures were performed in the US. Despite of surgical advances, pain and inflammation after ophthalmic surgery continues to be a burden on both patients and physicians. The treatment of postoperative pain is essential for hospitalized patients, but it is even more important for patients who are treated on an outpatient basis. This study will compare the efficacy and safety of clobetasol propionate ophthalmic nanoemulsion 0.05% to placebo, when administering one drop four times a day during 14 days after routine unilateral cataract surgery. Participants will undergo routine cataract surgery according to the ophthalmologist's normal procedures. Overall, 210 participants are planned to take part in the study. They will be screened across 20 centers in the US. Participants who experience postoperative inflammation on the first day following routine cataract surgery and who meet all other eligibility criteria will be randomly assigned by chance to one of two study groups in a 2:1 ratio to receive either clobetasol propionate ophthalmic nanoemulsion 0.05 % (N=140) or placebo (N=70) for the treatment of inflammation and pain associated with cataract surgery. Six (6) study visits are planned: Visit -1 (Screening), Visit 1 (Baseline; 24h after the surgery), Visit 2 (Day 3), Visit 3 (Day 8), Visit 4 (Day 15), and Visit 5 (Day 29). The ophthalmologist will administer the first dose of the study medication 24 hours after the surgery, at the end of the Baseline visit, at the study center. Study medication will be then dispensed to participants for self-administration during the study at a dosage of one drop four times a day, during 14 days. Direct instillation is the most efficient method for delivery to the ocular surface and is an accepted and widely used method for topical application to the eye. This study will examine effect and tolerability for 14 days of clobetasol propionate ophthalmic nanoemulsion 0.05% dosed four times a day. This study is being conducted to support an application for approval to market clobetasol propionate ophthalmic nanoemulsion 0.05% in the US for the indication of inflammation and pain after ocular surgery. The reference (comparator) product in this study, the vehicle, is expected to provide a lower efficacy rate when compared to clobetasol 0.05%.

NCT ID: NCT04241653 Completed - Cataract Surgery Clinical Trials

Impact of Different Modes of Ventilation With Laryngeal Mask Airway on Pediatric Cataract Surgery

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

This study will be conducted to evaluate effects of different modes of ventilation on pediatric cataract surgery aiming to a peri-operative stable anesthesia, better surgical satisfaction and post operative recovery. It is hypothesized that controlled ventilation without muscle relaxation will be advantageous to other modes in providing adequate surgical satisfaction with considerable depth of anesthesia and better recovery profile.

NCT ID: NCT04224155 Completed - Cataract Clinical Trials

Clinical Study to Evaluate the Safety and Performance of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the safety and performance of the enVista trifocal intraocular lens when implanted in the capsular bag.

NCT ID: NCT04220255 Completed - Cataract Clinical Trials

Clinical Outcome at 5 Years After Implantation of the Liberty677MY Multifocal Intraocular Lens

Start date: November 1, 2019
Phase:
Study type: Observational

The study will assess visual outcomes, light disturbances and patients' satisfaction after implantation with the Liberty677MY multifocal IOL, as well as protection of PCO development within 5 year follow-up.

NCT ID: NCT04220138 Completed - Cataract Senile Clinical Trials

Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex

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

With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.

NCT ID: NCT04210232 Completed - Cataract Clinical Trials

Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

Start date: January 14, 2020
Phase: N/A
Study type: Interventional

This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.

NCT ID: NCT04208633 Completed - Cataract Clinical Trials

Correlation Between Sulcus Anatomy and Other Parameters After Horizontal & Vertical Intraocular Lens (IOLs) Placements

Start date: September 14, 2016
Phase: N/A
Study type: Interventional

Usually following cataract surgery patients would expect to have normal distance vision and not require the use of distance glasses. However, in clinical practice desired vision post cataract surgery is not achieved sometimes. In such cases a piggyback lens is used to enhance the visual outcome. This lens is placed in the ciliary sulcus (space between the iris and the lens). Often this piggyback lens is not the best fit for the ciliary sulcus space and it moves. This study will be using ultrasound biomicroscopy to measure the ciliary sulcus dimensions pre and postoperatively to estimate the normal anatomy and it's variations. Patients in this study will be randomised as to which way the intraocular lens is placed in the eye (horizontally or vertically) at the time of their cataract surgery. Patients requiring cataract surgery in both eyes will be identified from the Eye Hospital at the Royal Sussex County Hospital. Patients will be in the study for up to 6 months from being identified as suitable through to the operation in the 2nd eye and a final study visit.

NCT ID: NCT04204954 Completed - Cataract Clinical Trials

Evaluation of Treatment Option for Demodicosis in Patients Undergoing Cataract Surgery

Start date: May 6, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Demodex blepharitis is a prevalent cause of comorbid infection among individuals undergoing cataract surgery. Several complications may arise in the postsurgical period from Staphylococcus or Streptococcus co-infections, as Demodex is a vector for these pathogens. Hence, prophylactic treatments before cataract surgery may lead to a reduction in complication rates. Since Demodex infestation and cataract surgery are two prevalent coexisting conditions in the general population, this study aims to test the effect of four combined treatments to eradicate or improve the Demodex infestation index before surgery. The investigators are conducting a single-blinded randomized trial of four therapies in participants undergoing cataract surgery. All participants will or are receiving daily eyelid cleansing bid and topical 0.3% ciprofloxacin q4h for three days added to the allocated treatment arm. Our four intervention groups are: [1] Blephaclean eye scrubs; [2] 50% dilution baby shampoo; [3] tea tree oil shampoo; [4]: topical 0.3% ciprofloxacin alone. To assess treatment efficacy, the investigators will perform eyelash hair epilation pre and postoperatively. The primary outcome is a change in the mean Demodex spp. infestation index. Also, a change in the crude number of Demodex (egg, larvae, nymph, or adult-form) spp. in eyelashes after one-week of therapy.

NCT ID: NCT04202562 Completed - Hypertension Clinical Trials

Efficacy and Safety of ab Interno Trabeculectomy With the Kahook Dual Blade

KDB
Start date: February 2, 2017
Phase: N/A
Study type: Interventional

The Kahook Dual Blade is a single-use device specially designed to create a clean cut in the trabecular meshwork. This ablation in the trabecular meshwork allows a better outflow of the aqueous humor, thus reducing the intraocular pressure (IOP), theoretically beyond the IOP reduction achieved by other minimally invasive glaucoma surgery (MIGS) devices. Studies already published showed good results in terms of the reduction of the number of glaucoma medications and the reduction in the IOP, but not a single study has been performed prospectively comparing the efficacy of the technique, not even with the cataract surgery.