Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- United Christian Hospital
- Enrollment
- 17
- Primary Endpoint
- Regression of neovascularization
Study Overview
Brief Summary
A randomized study to assess the safety and efficacy of single-session pan-retinal photocoagulation (PRP) using Pattern Scan Laser (PASCAL) in proliferative diabetic retinopathy (PDR) - 1,700 shots vs 2,500 shots
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November
Exclusion Criteria
- •significant media opacity affecting laser uptake (e.g. corneal opacity, mature cataract, dense vitreous haemorrhage)
- •any pre-existing ocular disorders resulting in visual impairment (e.g. retinal degenerations, maculopathies, primary glaucoma and other optic neuropathies)
- •those who received previous retinal laser treatment, intravitreal injections or intraocular surgeries
- •clinically significant macular oedema on clinical examination.
Arms & Interventions
1,700
Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
Intervention: Pan-retinal photocoagulation using pattern scanning laser (Device)
2,500
Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
Intervention: Pan-retinal photocoagulation using pattern scanning laser (Device)
Outcomes
Primary Outcomes
Regression of neovascularization
Time Frame: 3 months
Fluorescein angiogram assessment by independent observer
Secondary Outcomes
- Activity of neovascularization(3 months)
- Best corrected visual acuity(1 week, 1 month, 3 months, 6 months)
- Complications(1 week, 1 month, 3 months, 6 months)
- Central foveal thickness(1 week)
- Retreatment rate(6 months)
Investigators
Chung-yee Chung
Associate Consultant
United Christian Hospital