Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01304225

Enrollment

Registered

2011-02-25

Start date

2010-09-30

Completion date

2013-03-31

Last updated

2011-02-25

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

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy, photocoagulation, PASCAL laser

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.

Interventions

PROCEDUREPanretinal photocoagulation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Brazil

Contacts

Primary ContactRenato M Passos, MD

renatompassos@yahoo.com.br55 11 50852043

Outcome results

None listed

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