Posts

Corneal donor tissue can be stored for 11 days, says study

/0 Comments/in /by

Donor corneas, the eye’s clear outer covering, are generally not used for surgery if they have been preserved for longer than seven days.
Corneal donor tissue can be safely stored for 11 days without negatively impacting the success of a transplant, a clinical trial has shown.

Currently, donor corneas, the eye’s clear outer covering are generally not used for surgery if they have been preserved for longer than seven days.

Expanding the window in which donor tissues can be considered suitable “by even just a few days” should help safeguard quality donor tissue and access to vision-saving transplantation procedures, the researchers said.

“The current practice of surgeons to use corneas preserved for no longer than seven days is not evidence-based.

“Rather that practice is based on opinion, which hopefully will change with this new evidence,” said lead investigator Jonathan Lass, from the Case Western Reserve University.

For the study, appearing in the journal JAMA Ophthalmology, the team looked at three-year graft success rates among a total of 1,090 individuals (1,330 eyes) who underwent cornea transplant via Descemet’s stripping automated endothelial keratoplasty by 70 surgeons at 40 surgical sites.

Overall, the three-year success rates were the same for corneas preserved for eight-to-14 days compared with up to seven days (92.1 per cent versus 95.3 per cent).

In a separate analysis, the team analysed the extent of endothelial cell loss (ECL) — the loss of cells in the corneal endothelium that continued to occur as a normal part of ageing in the grafted donor cornea three years after it had been transplanted.

They non-invasively measured ECL in the 945 eyes with successful grafts and found that corneas preserved up to seven days had a 37 per cent loss of cells versus a 40 per cent loss in corneas preserved for eight-to-14 days.

Taken together, the separate analyses looked at graft success rates and ECL support that used corneas stored up to 11 days, the researchers said.

Source: http://zeenews.india.com/health/corneal-donor-tissue-can-be-stored-for-11-days-says-study-2056202

iMedWorks Ask Platform Links below:

1. Get a Medical Second Opinion
2. Search doctors and Request Appointment

Be careful: Use of off-label drugs to treat retinal diseases can lead to vision loss

/0 Comments/in /by

‘Off-label’ drug use is defined as use of a drug that has not cleared the necessary regulatory approval for specific diseases/ conditions and is therefore not an approved drug for the same.

There have been concerns about off-label drug use causing vision loss in the patients. Owing to multiple reports of vision loss and similar adverse events, experts have called out the heightened need for stringent patient safety guidelines to be formalised with immediate effect in India. Most of these adverse effects are being experienced by the patients with retinal diseases across the country, post alleged administration of off-label drug injections.

‘Off-label’ drug use is defined as use of a drug that has not cleared the necessary regulatory approval for specific diseases/ conditions and is therefore not an approved drug for the same. Allegedly, these drugs have not been approved for treating retinal diseases. In the above cases, vial of an off-label drug was prescribed and injected in patients, leading to bacterial infection in the eye. This infection, when left untreated, led to complete vision loss, as observed in these patients.

“Patient safety holds paramount importance in medical practice. Splitting of the same vial of the drug for multiple patients increases the risk of microbial infections and compromises the sterility of the drug. The recent incidents of vision loss experienced by retinal patients across the country were due to use of the same vial of an ‘off-label drug’ for multiple patients”, said Dr Sunandan Sood, Former HOD – Eye Department, Government Medical College and Hospital, Chandigarh. Sood continued, “In order to avoid such practices, policies focused on patient safety must be framed to ensure enforcement of stringent patient safety guidelines in the country”.

Current treatments for retinal diseases like Age-Related Macular Degeneration (AMD) and Diabetes Macular Edema (DME) are known to reduce the level of a protein called Vascular Endothelial Growth Factor (VEGF). This protein is responsible for abnormal blood vessel growth in the retina and macula. The drugs approved for the treatment of AMD and DME are anti-VEGF. Given the availability of efficacious anti-VEGF treatment options in the country, the use of an off-label drug without following proper procedures puts the patient safety at major risk.

Further stressing the adoption of stringent patient safety guidelines in India, Bejon Misra, Founder, Patient Safety and Access Initiative of India Foundation, a (PSM) India Initiative, said, “India is poised to provide a huge opportunity for patients to access quality medicines through the recently announced Pradhan Mantri Aushadi Parak Yojana (PM – APY). It, therefore, becomes crucial for pharmaceutical companies, medical practitioners and regulators to be more responsible towards patient safety and Quality Management Systems (QMS). Patient safety should be kept in mind and monitored judiciously on a drug-by-drug and administration basis and across all disease indications addressed by a particular drug.”

The World Health Organization (WHO) calls patient safety an endemic concern, recognizing that healthcare errors impact 1 in every 10 patients around the world. This number also includes adverse events due to drugs. The need of the hour for the pharma industry in India is to prioritise patient safety in addition to universal access to healthcare.

Source: https://www.hindustantimes.com/health/be-alert-use-of-off-label-drugs-to-treat-retinal-diseases-can-lead-to-vision-loss/story-OpZaU66qBqHkCVj1bNVIwJ.html

iMedWorks Ask Platform Links below:

1. Get a Medical Second Opinion
2. Search doctors and Request Appointment

One billion people may suffer from Glaucoma by 2030: AIIMS

/0 Comments/in /by

As the World Glaucoma Week ends on March 17, with over 11.2 million persons aged 40 years and older suffering from Glaucoma in India, researchers say that despite it being the second largest cause of blindness, it is more problematic than cataract, because the blindness caused by Glaucoma is irreversible. Over 70 per cent of the Indian population is at the risk of developing Glaucoma, of which 2 lakh are likely to lose vision on an average.

Doctors from the All Indian Institute of Medical Sciences (AIIMS) have already proposed in their research papers that type four diabetes can occur in the brain and is the suspected cause of Glaucoma and related neuro-degenerative disorders. Due to it being considered one of the most complex human diseases, a majority of those suffering from Glaucoma go undetected and major challenges exist in detecting and treating those with the disease.

“There are striking similarities in genetic, biochemical, and molecular aspects which prove that Glaucoma is a form of brain-specific diabetes. There might be one billion people suffering of it across the world by 2030. It is sometimes uncontrolled even by medicines and requires multiple surgeries and lifelong therapies. It is known to be a silent ailment that can lead to blindness and hence creating awareness among the masses is necessary to prevent it from becoming an epidemic,” said Dr Muneeb Faiq, Clinical Researcher, AIIMS.

According to the World Health Organisation (WHO), it is the second largest cause of blindness in the world and fourth largest in India. The average age for the prevalence of Glaucoma is over 50 years, but with sedentary lifestyle and westernisation, the average age is getting reduced. It has recently been observed that of the total cases diagnosed with the condition, over 70 per cent of them were under the age of 35.

“It is important to get optic nerve examinations done regularly and further educate people about the disease. People with a family history of diabetes, hypertension, and poor blood circulation are at an elevated risk of getting the condition,” said Dr Ritika Sachdev, Additional Director Medical Services, Centre for Sight.

WHO REPORT
Glaucoma is the 2nd largest cause of blindness in the world and 4th largest in India. The average age for prevalence of Glaucoma is over 50 years. But, it has been observed that of the total cases diagnosed, over 70% were under the age of 35.

Source: http://www.dnaindia.com/health/report-one-billion-people-may-suffer-from-glaucoma-by-2030-aiims-2594549

iMedWorks Ask Platform Links below:

1. Get a Medical Second Opinion
2. Search doctors and Request Appointment

US FDA approves first artificial iris

/0 Comments/in /by

The US Food and Drug Administration on Thursday approved the first stand-alone prosthetic iris, a surgically implanted device to treat adults and children whose iris is completely missing or damaged due to a congenital condition called aniridia or other damage to the eye.
Iris is the coloured part of the eye around the pupil.
Director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, Malvina Eydelman in a statement said patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye.
“Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.” he said.
The FDA granted approval of the “CustomFlex Artificial Iris” to HumanOptics AG a Germany-based firm that produces and distributes intraocular implants of the highest quality.
The CustomFlex Artificial Iris is made of thin, foldable medical-grade silicone and is custom-sized and colored for each individual patient.
A surgeon makes a small incision, inserts the device under the incision, unfolds it and smooths out the edges using surgical instruments.
The prosthetic iris is held in place by the anatomical structures of the eye or, if needed, by sutures, FDA said.
“The safety and effectiveness of the CustomFlex Artificial Iris was demonstrated primarily in a non-randomised clinical trial of 389 adult and paediatric patients with aniridia or other iris defects.”
The study measured patients’ self-reported decrease in severe sensitivity to light and glare post-procedure, health-related quality of life, and satisfaction with the cosmetic improvement or appearance of the prosthesis.
“More than 70 percent of patients reported significant decreases in light sensitivity and glare as well as an improvement in health-related quality of life following the procedure.
In addition, 94 percent of patients were satisfied with the artificial iris’ appearance,” the regulator said with regards to the efficacy of the artificial iris.
The study found low rates of adverse events associated with the device or the surgical procedure, it added.
The FDA also suggested that the CustomFlex Artificial Iris is contraindicated, or should not be used, in eyes under certain conditions such as uncontrolled or severe chronic inflammation (uveitis), abnormally small eye size (microphthalmus), untreated retinal detachment, untreated chronic glaucoma, and cataract caused by rubella virus.

Source: http://www.tribuneindia.com/news/health/us-fda-approves-first-artificial-iris/597985.html

(Picture for representation)

iMedWorks Ask Platform Links below:

1. Get a Medical Second Opinion
2. Search doctors and Request Appointment