Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

Single-session Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy - a Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02816073

Enrollment

Registered

2016-06-28

Start date

2012-12-31

Completion date

2016-04-30

Last updated

2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Lasers, Treatment Outcome

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

Interventions

DEVICEPan-retinal photocoagulation using pattern scanning laser

Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Regression of neovascularization	3 months	Fluorescein angiogram assessment by independent observer

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026