Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation

NCT02995629 | Completed

• 1 other identifier: 16-560
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to compare patient comfort when using the 532 nanometer (green) wavelength laser to the 577 nanometer (yellow) wavelength laser during pan retinal photocoagulation to treat patients with diabetic retinopathy. Secondary outcome measures will be power (mW) required to achieve gray-white retinal burns and duration of treatment.

Conditions

Proliferative Diabetic Retinopathy - High Risk

Outcome Measures

Primary Outcomes (1)

• Perceived patient pain assessment

  Assessed using a standardized Wong-Baker faces pain scale

  a single time point within 2 minutes of completing laser treatment

Secondary Outcomes (2)

• Minimum power requirement to achieve moderate gray-white retinal burns

  During treatment

• Time of treatment

  During treatment

Study Arms (2)

green (532 nm) laser

EXPERIMENTAL

scatter laser indirect ophthalmoscopy pan retinal photocoagulation

Procedure: laser indirect ophthalmoscopy pan retinal photocoagulation

yellow (577 nm) laser

EXPERIMENTAL

scatter laser indirect ophthalmoscopy pan retinal photocoagulation

Procedure: laser indirect ophthalmoscopy pan retinal photocoagulation

Interventions

laser indirect ophthalmoscopy pan retinal photocoagulation PROCEDURE

* 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

Also known as: PRP laser

green (532 nm) laser; yellow (577 nm) laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient of Wills Eye Hospital Retina Service and/or Mid Atlantic Retina
• 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.

You may not qualify if:

• patient less than 18 years of age
• 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

Sponsors & Collaborators

• Wills Eye: lead
• Mid Atlantic Retina: collaborator

Study Sites (1)

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (12)

• 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.

  PMID: 7196564 BACKGROUND

• 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.

  PMID: 19169228 BACKGROUND

• 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.

  PMID: 20608612 BACKGROUND

• 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.

  PMID: 23052718 BACKGROUND

• 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.

  PMID: 16021194 BACKGROUND

• 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.

  PMID: 20046687 BACKGROUND

• 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.

  PMID: 19376588 BACKGROUND

• 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.

  PMID: 20570360 BACKGROUND

• 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.

  PMID: 21978192 BACKGROUND

• 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.

  PMID: 25719988 BACKGROUND

• 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.

  PMID: 25613846 BACKGROUND

• 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.

  PMID: 3763141 BACKGROUND

Study Officials

• Allen Chiang, MD

  Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Allen Chiang, MD

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 16, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)