NCT01304225

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

1.5 years

First QC Date

February 24, 2011

Last Update Submit

February 24, 2011

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathyphotocoagulationPASCAL laser

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 year

Secondary Outcomes (3)

  • Clinical involution of retinal new vessels

    1 year

  • Nerve fiber layer thickness

    1 year

  • Retinal sensitivity

    1 year

Study Arms (3)

100ms single-shot

ACTIVE COMPARATOR

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

Procedure: Panretinal photocoagulation

20ms multiple-shot

EXPERIMENTAL

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

Procedure: Panretinal photocoagulation

20ms multiple-shot, barely visible

EXPERIMENTAL

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

Procedure: Panretinal photocoagulation

Interventions

Panretinal photocoagulationPROCEDURE

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

100ms single-shot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Federal University of São Paulo

São Paulo, São Paulo, 04023062, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 19714265BACKGROUND

  • 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.

    PMID: 20385940BACKGROUND

  • 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.

    PMID: 20457972BACKGROUND

  • 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.

    PMID: 20216293BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Renato M Passos, MD

CONTACT

55 11 50852043renatompassos@yahoo.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2013

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations

BR(1)