Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

NCT ID: NCT01304225

Last Updated: 2011-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Diabetic Retinopathy

Keywords

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diabetic retinopathy photocoagulation PASCAL laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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100ms single-shot

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

Group Type ACTIVE_COMPARATOR

Panretinal photocoagulation

Intervention Type PROCEDURE

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

20ms multiple-shot

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

Group Type EXPERIMENTAL

Panretinal photocoagulation

Intervention Type PROCEDURE

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

20ms multiple-shot, barely visible

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

Group Type EXPERIMENTAL

Panretinal photocoagulation

Intervention Type PROCEDURE

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

Interventions

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Panretinal photocoagulation

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

Intervention Type PROCEDURE

Panretinal photocoagulation

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

Intervention Type PROCEDURE

Panretinal photocoagulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Doctor at the Ophthalmology Department of UNIFESP

Locations

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Department of Ophthalmology, Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Renato M Passos, MD

Role: CONTACT

Phone: 55 11 50852043

Email: [email protected]

References

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Modi D, Chiranand P, Akduman L. Efficacy of patterned scan laser in treatment of macular edema and retinal neovascularization. Clin Ophthalmol. 2009;3:465-70. doi: 10.2147/opth.s6486. Epub 2009 Aug 20.

Reference Type BACKGROUND
PMID: 19714265 (View on PubMed)

Muqit MM, Gray JC, Marcellino GR, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Dick AD, Stanga PE. In vivo laser-tissue interactions and healing responses from 20- vs 100-millisecond pulse Pascal photocoagulation burns. Arch Ophthalmol. 2010 Apr;128(4):448-55. doi: 10.1001/archophthalmol.2010.36.

Reference Type BACKGROUND
PMID: 20385940 (View on PubMed)

Muqit MM, Marcellino GR, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Stanga PE. Single-session vs multiple-session pattern scanning laser panretinal photocoagulation in proliferative diabetic retinopathy: The Manchester Pascal Study. Arch Ophthalmol. 2010 May;128(5):525-33. doi: 10.1001/archophthalmol.2010.60.

Reference Type BACKGROUND
PMID: 20457972 (View on PubMed)

Nagpal M, Marlecha S, Nagpal K. Comparison of laser photocoagulation for diabetic retinopathy using 532-nm standard laser versus multispot pattern scan laser. Retina. 2010 Mar;30(3):452-8. doi: 10.1097/IAE.0b013e3181c70127.

Reference Type BACKGROUND
PMID: 20216293 (View on PubMed)

Other Identifiers

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PASCAL-001

Identifier Type: -

Identifier Source: org_study_id