Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01304225
• Other study ID #: PASCAL-001
• Status: Recruiting
• Phase: Phase 3
• First received: February 24, 2011
• Last updated: February 24, 2011
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: February 2011
• Source: Federal University of São Paulo
• Contact: Renato M Passos, MD
• Phone: 55 11 50852043
• Email: renatompassos[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Brazil	Department of Ophthalmology, Federal University of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. Epub 2009 Aug 20. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Clinical involution of retinal new vessels	Clinical involution of retinal new vessels will be evaluated with retinography and fluorescein angiography	1 year	No
Secondary	Nerve fiber layer thickness	Nerve fiber layer thickness will be evaluated with Spectral Domain OCT	1 year	Yes
Secondary	Retinal sensitivity	Retinal sensitivity will be evaluated with Humphrey computerized perimetry and FDT (Frequency Doubling Technology)	1 year	Yes