Clinical trial NCT01304225: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
photocoagulation
PASCAL laser
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of severe visual loss after 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Clinical involution of retinal new vessels
timeFrame: 1 year
measure: Nerve fiber layer thickness
timeFrame: 1 year
measure: Retinal sensitivity
timeFrame: 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Ophthalmology, Federal University of São Paulo
state: SP
Study officials:
References:
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.
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.
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.
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.