Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Procedure: Panretinal photocoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01304225

PASCAL-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

100ms single-shot

Active Comparator group

Description:

Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion

Treatment:

Procedure: Panretinal photocoagulation

Procedure: Panretinal photocoagulation

Procedure: Panretinal photocoagulation

20ms multiple-shot

Experimental group

Description:

Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion

Treatment:

Procedure: Panretinal photocoagulation

Procedure: Panretinal photocoagulation

Procedure: Panretinal photocoagulation

20ms multiple-shot, barely visible

Experimental group

Description:

Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion

Treatment:

Procedure: Panretinal photocoagulation

Procedure: Panretinal photocoagulation

Procedure: Panretinal photocoagulation