Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816073
• Other study ID #: 12-0079
• Status: Completed
• Phase: N/A
• First received: June 21, 2016
• Last updated: June 28, 2016
• Start date: December 2012
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: United Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2016
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Lasers
• Retinal Diseases
• Treatment Outcome

Intervention

Device:
• Pan-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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
United Christian Hospital	The University of Hong Kong

Outcome

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