This trial is evaluating whether APP13007, 0.05% will improve 5 primary outcomes and 5 secondary outcomes in patients with Cataract. Measurement will happen over the course of Through Postoperative Day 15.
This trial requires 370 total participants across 2 different treatment groups
This trial involves 2 different treatments. APP13007, 0.05% is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Approximately 9 million US adults over the age of 65 have cataract, and of these, it is estimated that 6.4 million will have vision-threatening cataract by age 75.
A number of people have signs and symptoms of cataract, but they are not normally identified and investigated by their optometrist or ophthalmologist. Visual acuity may not decrease by 50% over a period of ten years, even in the severe cases. Some patients have only minor symptoms and may be reassured. The diagnosis should then be questioned by an urgent referral to a specialist. The most common signs of cataract are a gradual loss of distance vision, the appearance of a cataract in one or both eyes, with blurred vision of near objects, and with glare which can be seen with very low lights, on cloudy days, and at night, especially when reading.
What is cataract? Cataract is a kind of lens opacity in the eye. It happens when the lens capsule starts to leak fluid and it takes several years. In the elderly it is very common. If cataract is left untreated, the lens will begin to disintegrate causing water to leak out, making it hazel coloured and gradually opaque. Cataract affects 3% of the US population.\n
The study was conducted using a large sample size from a single US cohort to ascertain whether there is significant association between cataract and vitreous hemorrhage. There was not. The study was limited by its retrospective nature, retrospective design and small sample size.
The best evidence supports the notion that cataract, in conjunction with glaucoma and other eye disorders, is better treated with surgery. However, many surgeons in this group are unable to agree because of conflicting evidence to the best surgical procedure. The best surgical procedure should be determined by individual ophthalmologists. Surgical procedures are not the same in every eye clinic.
Patient's willingness to pay the most for cataract surgery differed significantly and there were correlations with certain patient perceptions, particularly about the need for surgery and the severity of disease. The information provided by eye care professionals regarding the options of treatment also influenced the decision to proceed with surgery. More research is required to better understand the patient's decision-making process concerning treatment.
A review on the surgical techniques for cataract, the most recent research on different types of laser light source, implantable intraocular lens and use of drugs for corneal diseases, retinal disorders, and ocular diseases.
This is the first large, prospective study examining the efficacy of AP13007 in phakic, open cataract. AP13007 was non-inferior to BPT with respect to the following efficacy endpoints: achieving visual acuity >6/12, achieving VA >0.6, achieving VA >0.40, and maintaining VA ≥0.70 throughout 12–36 months. The safety profile of AP13007 was very favorable, demonstrating favorable changes from baseline in ocular and general health for 2 years post-procedure.
Clinical trials to evaluate medicines, devices or treatment modes are worthwhile, but the number of these trials should be increased. Given the long duration of cataract, it seems prudent to have a randomised trial for cataract evaluating the timing of surgery. The main issue when planning clinical trials for cataract is to be mindful of the difficulties and high numbers of patients required.
The average age in which one would start to get a cataract is 57.1 years and the latest age in which an eye could have cataract is 72.8 years. It is difficult to get the actual patient’s age because it is a delicate and intimate matter that should be kept confidential.. The earlier an eye is diagnosed, the higher is the chances of getting to the right treatment. Therefore, patients should come in to the clinic for proper treatment of their cataract as soon as they start having trouble with their vision.
The patient should be informed in advance about the treatment in order to have an overview of the risks and benefits or treatment options. All eye surgeons must be thoroughly educated about the new technology and how a patient should be prepared by a nurse. A well informed patient will be well informed on the matter. To minimize the adverse side effects a patient should be thoroughly informed of the use of a soft contact lens in the eye before the surgery. For those of you that are already using a contact lens, you can continue. However after the surgery, a patient should start using the soft contact lens immediately. If you are not, the eye should be checked for corneal abrasions immediately after the surgery and again in 2 weeks time.
The current study suggests that the ophthalmologist should be aware that, even when an agent is considered to have a very low or no documented safety, the combined use of the agent with a previously developed agent is often necessary to create the maximal benefit.