Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

Phase 3

• Conditions: Diabetic Retinopathy

• Registration Number: NCT01304225
• Lead Sponsor: Federal University of São Paulo

Brief Summary

This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. The investigators believe that using "lower" laser parameters, the clinical response may be equivalent with less adverse effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Status Verified: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Last Update Submitted: 2011-02-24
• Study First Posted: 2011-02-25
• Last Update Posted: 2011-02-25
• Primary Completion: 2012-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• proliferative or severe nonproliferative diabetic retinopathy (type 1 or type 2)
• best corrected visual acuity of 20/50 or better
• capability to read and follow instructions
• capability to sign the consignment term

Exclusion Criteria

• best corrected visual acuity worse than 20/50
• significant macular edema responsible for visual acuity lower than 20/50
• media opacities (includes vitreous hemorrhage in the visual axis, but not a reabsorbing inferior vitreous hemorrhage)
• previous laser treatment (PRP, focal or macular grid)
• glaucoma (confirmed or suspicious)
• other diseases of the retina and optic nerve
• previous ocular surgery in the last 6 months
• impossibility to obtain good quality images of retinography, angiography or OCT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of severe visual loss after 1 year	1 year	Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)

Secondary Outcome Measures

Name	Time	Method
Clinical involution of retinal new vessels	1 year	Clinical involution of retinal new vessels will be evaluated with retinography and fluorescein angiography
Nerve fiber layer thickness	1 year	Nerve fiber layer thickness will be evaluated with Spectral Domain OCT
Retinal sensitivity	1 year	Retinal sensitivity will be evaluated with Humphrey computerized perimetry and FDT (Frequency Doubling Technology)

Trial Locations

Locations (1)

Department of Ophthalmology, Federal University of São Paulo; 🇧🇷 São Paulo, SP, Brazil