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Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

Primary Purpose

Diabetic Retinopathy

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Panretinal photocoagulation
Panretinal photocoagulation
Panretinal photocoagulation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, photocoagulation, PASCAL laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Ophthalmology, Federal University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

100ms single-shot

20ms multiple-shot

20ms multiple-shot, barely visible

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Incidence of severe visual loss after 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

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

Full Information

First Posted
February 24, 2011
Last Updated
February 24, 2011
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01304225
Brief Title
Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser
Official Title
Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy, photocoagulation, PASCAL laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
100ms single-shot
Arm Type
Active Comparator
Arm Description
Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
Arm Title
20ms multiple-shot
Arm Type
Experimental
Arm Description
Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
Arm Title
20ms multiple-shot, barely visible
Arm Type
Experimental
Arm Description
Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion
Intervention Type
Procedure
Intervention Name(s)
Panretinal photocoagulation
Intervention Description
Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
Intervention Type
Procedure
Intervention Name(s)
Panretinal photocoagulation
Intervention Description
Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
Intervention Type
Procedure
Intervention Name(s)
Panretinal photocoagulation
Intervention Description
Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion
Primary Outcome Measure Information:
Title
Incidence of severe visual loss after 1 year
Description
Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical involution of retinal new vessels
Description
Clinical involution of retinal new vessels will be evaluated with retinography and fluorescein angiography
Time Frame
1 year
Title
Nerve fiber layer thickness
Description
Nerve fiber layer thickness will be evaluated with Spectral Domain OCT
Time Frame
1 year
Title
Retinal sensitivity
Description
Retinal sensitivity will be evaluated with Humphrey computerized perimetry and FDT (Frequency Doubling Technology)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renato M Passos, MD
Phone
55 11 50852043
Email
renatompassos@yahoo.com.br
Facility Information:
Facility Name
Department of Ophthalmology, Federal University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023062
Country
Brazil
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
19714265
Citation
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.
Results Reference
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PubMed Identifier
20385940
Citation
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.
Results Reference
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PubMed Identifier
20457972
Citation
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.
Results Reference
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PubMed Identifier
20216293
Citation
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.
Results Reference
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Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

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