Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic Retinopathy

NCT02816073 | Completed

• 1 other identifier: 12-0079
• Study Type: interventional
• Target: 17
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetic Retinopathy; Lasers; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• Regression of neovascularization

  Fluorescein angiogram assessment by independent observer

  3 months

Secondary Outcomes (5)

• 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

Study Arms (2)

1,700

ACTIVE COMPARATOR

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

Device: Pan-retinal photocoagulation using pattern scanning laser

2,500

ACTIVE COMPARATOR

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

Device: Pan-retinal photocoagulation using pattern scanning laser

Interventions

Pan-retinal photocoagulation using pattern scanning laser DEVICE

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

1,700; 2,500

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All treatment-naïve patients with proliferative diabetic retinopathy (PDR) who attended our ophthalmic clinic from 1st December 2012 to 30th November

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Christian Hospital: lead
• The University of Hong Kong: collaborator

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Kenneth KW Li, MBChB

  United Christian Hospital; The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2016
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06