Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

Not Applicable

Completed

• Conditions: Lasers; Treatment Outcome; Diabetic Retinopathy
• Interventions: Device: Pan-retinal photocoagulation using pattern scanning laser

• Registration Number: NCT02816073
• Lead Sponsor: United Christian Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-11
• Study Completion: 2016-04
• Status Verified: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1,700	Pan-retinal photocoagulation using pattern scanning laser	Patients receive 1,700 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser
2,500	Pan-retinal photocoagulation using pattern scanning laser	Patients receive 2,500 (+/- 5%) laser shots in a single session of pan-retinal photocoagulation using pattern scanning laser

Primary Outcome Measures

Name	Time	Method
Regression of neovascularization	3 months	Fluorescein angiogram assessment by independent observer

Secondary Outcome Measures

Name	Time	Method
Activity of neovascularization	3 months	Descriptive analysis of fundus fluorescein angiogram by independent observer into 4 categories: no leakage, reduced leakage, same leakage, increased leakage
Best corrected visual acuity	1 week, 1 month, 3 months, 6 months
Complications	1 week, 1 month, 3 months, 6 months	choroidal detachment, exudative retinal detachment, retinal breaks
Central foveal thickness	1 week	Measured by spectral domain optical coherence tomography (Heidelberg Spectralis)
Retreatment rate	6 months	Patients requiring retreatment with pan-retinal photocoagulation