Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser
NCT ID: NCT01304225
Last Updated: 2011-02-25
Study Results
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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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2010-09-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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100ms single-shot
Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
Panretinal photocoagulation
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
Panretinal photocoagulation
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
Panretinal photocoagulation
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
Panretinal photocoagulation
Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
Panretinal photocoagulation
Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion
Eligibility Criteria
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Inclusion Criteria
* best corrected visual acuity of 20/50 or better
* capability to read and follow instructions
* capability to sign the consignment term
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
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
Countries
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Central Contacts
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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.
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.
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.
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.
Other Identifiers
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PASCAL-001
Identifier Type: -
Identifier Source: org_study_id