None listed
Conditions
Brief summary
Dry eye disease affects between 5 and 50% of the population. In many cases, dry eye disease is idiopathic, however dry eye disease secondary to systemic disease has been identified as a major risk factor in the 2017 Tear Film and Ocular Surface Dry Eye Workshop II (TFOS DEWSII) report. In a study of 199 patients with type 2 diabetes, 54.3% were found to have dry eye disease, with dry eye frequency correlating with the duration of diabetes, where a 100% frequency was reported in patients who had a history of diabetes of greater than 15 years. The concurrent presence of dry eye disease in diabetes poses an additional risk to a potentially already compromised ocular surface: diabetes is known to increase the risk of corneal erosion formation, neurotrophic ulceration and persistent epithelial defects. Diabetes is currently estimated to affect 1.7 million Australians, with this figure predicted to rise to 3 million by 2025. It is associated with a multitude of microvascular and macrovascular complications due to the widespread effects of hyperglycaemia on the body’s various systems. The most commonly recognized diabetes-related complications are diabetic retinopathy and diabetic peripheral neuropathy. The prevalence of diabetic neuropathy is 26.4%15-70% depending on the method of detection used. The prevalence rises to 50% following 10 years of disease duration in type 2 diabetes. The clinical consequences are neuropathic pain, weakness with an increased risk of falls, and loss of sensation which may progress to foot ulceration and even amputation. The cornea, being one of the most densely innervated tissues, contains myelinated A-d and unmyelinated C fibers and has been advocated as a surrogate measure of peripheral neuropathy. We, and others, have previously reported a reduction in corneal nerve fiber length, fiber density and branch density with increasing neuropathic severity in both type 1 and type 2 diabetes. We hypothesize that the presence of neuropathy will increase the prevalence and severity of dry eye disease among those with diabetes. We further hypothesize that treating those with secondary dry eye disease with Systane Hydration will reduce these signs and symptoms, whether or not there is existing neuropathy. Primary Objective: This study will establish the odds of dry eye disease in diabetes when neuropathy is present, compared to diabetes without neuropathy (phase 1). Secondary objectives: This study will establish whether regular ocular lubrication with Systane Hydration can alleviate the signs and symptoms of secondary dry eye disease, whether it be due to diabetes alone or diabetic neuropathy (phase 2).
Interventions
One drop will be instilled per eye, four times a day. Compliance will be monitored by counting the number of vials used.
There will be a two week washout between treatments.
In phase 1, a sample of 60 participants with type 2 diabetes will be tested for the signs of dry eye disease and neuropathy. We estimate that approximately half will have the signs and symptoms of dry eye disease. This group will proceed to the next phase of the study, that is treatment. In phase 2, 30 participants will
One drop will be instilled per eye, four times a day. Compliance will be monitored by counting the number of vials used. There will be a two week washout between treatments. In phase 1, a sample of 60 participants with type 2 diabetes will be tested for the signs of dry eye disease and neuropathy. We estimate that approximately half will have the signs and symptoms of dry eye disease. This group will proceed to the next phase of the study, that is treatment. In phase 2, 30 participants will be randomised to Systane Hydration or saline for one month and a further one month with the alternate drop. One drop will be instilled per eye, four times a day. Compliance will be monitored by counting the number of vials used. There will be a two week washout between treatments.
Sponsors
UNSW
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For the first phase of the study, participants with type 2 diabetes will be recruited and examined for the signs and symptoms of dry eye disease. Participants will be at least 18 years of age. To be included in the second phase of the study, participants will need to have neuropathy AND an OSDI score greater than or equal to 12, as well as one of the following: the presence of either corneal or conjunctival staining, a tear break-up time of <10 seconds, or osmolarity greater than or equal to 308 mOsm/L in either eye or interocular difference > 8mOsm/L. An approximately equal number of mild, moderate and severe dry eye participants will be recruited based on the OSDI scores (mild >12-17; moderate 18-35; severe 36-100). The group receiving Systane Hydration first and the group receiving saline first will be age-matched, with similar body mass index (BMI), duration of diabetes, neuropathy severity and gender distribution and will be recruited from the Diabetes Centre at the Prince of Wales Hospital, Sydney, Australia. We have shown that age can impact on both the signs and symptoms of dry eye disease as well as the presence of corneal nerves and dendritic cells. Therefore age will be carefully controlled between groups.
Exclusion criteria
Patients will be excluded from the study if they have a history of other medical illnesses known to be associated with neuropathy. Exclusion criteria include malignant disease, connective tissue disease or infectious disease, neurotoxin exposure, deficiency of vitamin B12, family history of neuropathy or active diabetic foot ulcers. Patients will also be excluded from the study if they present with current eye infections, corneal abrasions, or a history of refractive surgery, eye surgery within 12 weeks immediately prior to study enrolment, contact lens wear, anterior segment trauma or are taking ocular medication category S3.
Outcome results
None listed