None listed
Conditions
Brief summary
Macular oedema (swelling of the central retina) is the commonest cause of visual loss in people with diabetes. Monthly injections of Anti VEGF are superior to conventional laser treatment when there is moderate visual loss from central macular oedema. However, monthly injections are less practical in central Australia and laser may be more effective than injections in many common clinical scenarios. Our pilot audit showed that results from laser in central Australia were equivalent to some of the original published cohorts of laser treatment. This study planned to audit results of laser treatment for diabetic maculopathy in central Australia over a longer period, and identify scenarios where laser remains an effective and affordable option in the treatment of diabetic maculopathy
Interventions
Exposure arm = When lasers were found ineffective, anti-VEGFs (0.05ml avastin or lucentis) were administered on an as required basis as per standard care, and were not prescribed as part of this study.
Laser treatment parameters were administered at the discretion of the treating clinician as per standard care.
Anti VEGF drugs used– avastin or lucentis
1. Intravitreal Bevacizumab (Avastin) 1.25mg/0.05ml administered every 4 to 6 weeks initially or as required
2. Intravitreal Ranibizumab (Luce
Exposure arm = When lasers were found ineffective, anti-VEGFs (0.05ml avastin or lucentis) were administered on an as required basis as per standard care, and were not prescribed as part of this study. Laser treatment parameters were administered at the discretion of the treating clinician as per standard care. Anti VEGF drugs used– avastin or lucentis 1. Intravitreal Bevacizumab (Avastin) 1.25mg/0.05ml administered every 4 to 6 weeks initially or as required 2. Intravitreal Ranibizumab (Lucentis) 0.5mg/0.05ml administered every 4 to 6 weeks initially or as required Ophthalmologist (TH) and Head of Department delivered the treatment/intervention as a day procedure in the Ophthalmology Department of the Alice Springs Hospital and its remote affiliate hospitals Mode of delivery for injections was face-to-face service provision This is an observational study where patients were followed up based on the severity of disease. The following time frames were usually followed: Clinically significant macular edema – every 4-6 weeks until resolved Non-proliferative Diabetic retinopathy (mild) – once a year Non-proliferative Diabetic retinopathy (moderate) – Twice/year Non-proliferative Diabetic retinopathy (severe) – every 4-6 months Pre-proliferate Diabetic retinopathy – Every 3-months Adherence to supplementary injections following laser treatment for progression of sight-threatening diabetic maculopathy was tracked from clinical file audits between the years 2001 and 2013. The duration of the follow-up period for this study for each participant was until stabilisation or improvement of retinopathy symptoms or features, whichever occurred first.
Sponsors
Alice Springs Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria were as follows: diabetic retinopathy patients receiving focal or macular photocoagulation at Alice Springs Hospital and/or Tennant Creek Hospital and those receiving treatment during outreach visits to remote communities. Patients were included in the study irrespective of racial background, age, location, co-morbidities and cataract status.
Exclusion criteria
Patient data were excluded from study for the following reasons: 1. Deceased patients whose files were not accessible as those files were transferred to Iron Mountain (a repository for medical records of deceased patients) in Darwin for storage. 2. Patients whose HRN or DOB or Names did not exist in the hospital system, and despite best efforts remained unidentifiable 3. Patients receiving laser photocoagulation for other visual problems un-related to diabetic retinopathy 4. Patients whose files were lost or had no follow up after the first injection to analyze the treatment effect
Outcome results
None listed