Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation
NCT ID: NCT02995629
Last Updated: 2016-12-16
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-03-31
2016-10-31
Brief Summary
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Detailed Description
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Currently, green lasers (521 - 532 nm wavelength) are most commonly utilized for performing PRP in clinical practice. Yellow lasers (577 nm wavelength) have been of recent interest in treating diabetic macular edema with micropulse subthreshold grid photocoagulation, but have not been extensively studied in PRP for diabetic retinopathy. Compared to shorter wavelength laser, yellow laser comports high transmission through dense ocular media and less light scattering than shorter wavelengths which minimizes spot size and reduces thermal spread. The limited literature comparing green and yellow laser for PRP in diabetic retinopathy has shown that yellow laser requires less power to achieve a retinal burn. In theory this should translate into a reduction in perceived pain experienced during PRP, however a comparison of green and yellow lasers in this regard has not yet been directly examined and quantified.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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green (532 nm) laser
scatter laser indirect ophthalmoscopy pan retinal photocoagulation
laser indirect ophthalmoscopy pan retinal photocoagulation
* Prior to procedure, eligible patient is dilated and a topical anesthesia is administered 3 to 5 minutes prior to treatment initiation
* Treatment duration is fixed at 50 minutes and power is titrated until moderate gray-white burns are achieved, avoiding long ciliary nerves
* Target treatment of 250 spots
* Only one eye per eligible patient randomized with regard to whether green or yellow laser utilized first
* After treatment,pain assessment conducted:spot count, laser parameters and treatment duration recorded for each respective laser wavelength
yellow (577 nm) laser
scatter laser indirect ophthalmoscopy pan retinal photocoagulation
laser indirect ophthalmoscopy pan retinal photocoagulation
* Prior to procedure, eligible patient is dilated and a topical anesthesia is administered 3 to 5 minutes prior to treatment initiation
* Treatment duration is fixed at 50 minutes and power is titrated until moderate gray-white burns are achieved, avoiding long ciliary nerves
* Target treatment of 250 spots
* Only one eye per eligible patient randomized with regard to whether green or yellow laser utilized first
* After treatment,pain assessment conducted:spot count, laser parameters and treatment duration recorded for each respective laser wavelength
Interventions
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laser indirect ophthalmoscopy pan retinal photocoagulation
* Prior to procedure, eligible patient is dilated and a topical anesthesia is administered 3 to 5 minutes prior to treatment initiation
* Treatment duration is fixed at 50 minutes and power is titrated until moderate gray-white burns are achieved, avoiding long ciliary nerves
* Target treatment of 250 spots
* Only one eye per eligible patient randomized with regard to whether green or yellow laser utilized first
* After treatment,pain assessment conducted:spot count, laser parameters and treatment duration recorded for each respective laser wavelength
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* volunteer patients age 18 years and older.
* healthy enough to participate in the study.
* willing and able to consent to participation in the study.
* diagnosis of PDR with HRC based on clinical criteria outlined by the DRS.
Exclusion Criteria
* institutionalized patient
* prisoner
* significant media opacity obscuring a view of the superior retina
* history of intra-ocular surgery except cataract surgery
* history of PRP laser within the last 30 days
18 Years
ALL
No
Sponsors
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Mid Atlantic Retina
OTHER
Wills Eye
OTHER
Responsible Party
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MidAtlantic Retina
Dr. Allen Chiang, MD
Principal Investigators
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Allen Chiang, MD
Role: PRINCIPAL_INVESTIGATOR
Mid Atlantic Retina
Locations
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Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States
Countries
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References
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Photocoagulation treatment of proliferative diabetic retinopathy. Clinical application of Diabetic Retinopathy Study (DRS) findings, DRS Report Number 8. The Diabetic Retinopathy Study Research Group. Ophthalmology. 1981 Jul;88(7):583-600.
Richardson C, Waterman H. Pain relief during panretinal photocoagulation for diabetic retinopathy: a national survey. Eye (Lond). 2009 Dec;23(12):2233-7. doi: 10.1038/eye.2008.421.
Alvarez-Verduzco O, Garcia-Aguirre G, Lopez-Ramos Mde L, Vera-Rodriguez S, Guerrero-Naranjo JL, Morales-Canton V. Reduction of fluence to decrease pain during panretinal photocoagulation in diabetic patients. Ophthalmic Surg Lasers Imaging. 2010 Jul-Aug;41(4):432-6. doi: 10.3928/15428877-20100525-02. Epub 2010 May 28.
Mirshahi A, Lashay A, Roozbahani M, Fard MA, Molaie S, Mireshghi M, Zaferani MM. Pain score of patients undergoing single spot, short pulse laser versus conventional laser for diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1103-7. doi: 10.1007/s00417-012-2167-5. Epub 2012 Oct 11.
Wu WC, Hsu KH, Chen TL, Hwang YS, Lin KK, Li LM, Shih CP, Lai CC. Interventions for relieving pain associated with panretinal photocoagulation: a prospective randomized trial. Eye (Lond). 2006 Jun;20(6):712-9. doi: 10.1038/sj.eye.6701989. Epub 2005 Jul 8.
Ko BW, Shim JH, Lee BR, Cho HY. Analgesic effects of tramadol during panretinal photocoagulation. Korean J Ophthalmol. 2009 Dec;23(4):273-6. doi: 10.3341/kjo.2009.23.4.273. Epub 2009 Dec 4.
Zakrzewski PA, O'Donnell HL, Lam WC. Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. Ophthalmology. 2009 Jun;116(6):1168-74. doi: 10.1016/j.ophtha.2009.01.022. Epub 2009 Apr 19.
Tesha PE, Giavedoni LR, Berger AR, Altomare F, Chow DR, Navajas EV, Yoganathan P, Wong DT, Principe A. Subconjunctival lidocaine before laser treatment: a randomized trial. Ophthalmology. 2010 Sep;117(9):1810-4. doi: 10.1016/j.ophtha.2010.01.036. Epub 2010 Jun 8.
Chiu HH, Wu PC. Manual acupuncture for relieving pain associated with panretinal photocoagulation. J Altern Complement Med. 2011 Oct;17(10):915-21. doi: 10.1089/acm.2010.0082. Epub 2011 Oct 6.
Vujosevic S, Martini F, Longhin E, Convento E, Cavarzeran F, Midena E. SUBTHRESHOLD MICROPULSE YELLOW LASER VERSUS SUBTHRESHOLD MICROPULSE INFRARED LASER IN CENTER-INVOLVING DIABETIC MACULAR EDEMA: Morphologic and Functional Safety. Retina. 2015 Aug;35(8):1594-603. doi: 10.1097/IAE.0000000000000521.
Yadav NK, Jayadev C, Mohan A, Vijayan P, Battu R, Dabir S, Shetty B, Shetty R; Medscape. Subthreshold micropulse yellow laser (577 nm) in chronic central serous chorioretinopathy: safety profile and treatment outcome. Eye (Lond). 2015 Feb;29(2):258-64; quiz 265. doi: 10.1038/eye.2014.315. Epub 2015 Jan 23.
Mainster MA. Wavelength selection in macular photocoagulation. Tissue optics, thermal effects, and laser systems. Ophthalmology. 1986 Jul;93(7):952-8. doi: 10.1016/s0161-6420(86)33637-6.
Other Identifiers
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16-560
Identifier Type: -
Identifier Source: org_study_id