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Cataract clinical trials

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NCT ID: NCT04265820 Recruiting - Cataract Clinical Trials

Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients

Start date: October 28, 2019
Phase: N/A
Study type: Interventional

This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens(IOLs) in cataract patients.

NCT ID: NCT04262596 Completed - Clinical trials for Age-related Cataract

Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

To compare the effectiveness of an interactive mobile chatbot and traditional decision aid booklets to enhance informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate ChatGPT-level responses.

NCT ID: NCT04255706 Completed - Cataract Senile Clinical Trials

Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Start date: November 25, 2019
Phase: N/A
Study type: Interventional

Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one. Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.

NCT ID: NCT04252716 Completed - Cataract Senile Clinical Trials

VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

VISPER
Start date: September 24, 2020
Phase:
Study type: Observational

To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013

NCT ID: NCT04249492 Active, not recruiting - Cataract Clinical Trials

PMCF Study on EDOF (Isopure) vs Monofocal (Micropure) IOL

PHY2001
Start date: February 11, 2020
Phase: N/A
Study type: Interventional

Multicenter, prospective, randomised, controlled, single-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of an enhanced depth of focus (EDOF) IOL with the outcomes obtained with a monofocal lens. Implantation of the IOLs is bilaterally.

NCT ID: NCT04249076 Completed - Cataract Clinical Trials

Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)

CLOSE-2
Start date: June 4, 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 patients 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: 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: NCT04246346 Recruiting - Clinical trials for Age-related Cataract

Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.

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.