Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation
Primary Purpose
Proliferative Diabetic Retinopathy - High Risk
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
laser indirect ophthalmoscopy pan retinal photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Diabetic Retinopathy - High Risk
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Mid Atlantic Retina- Wills Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
green (532 nm) laser
yellow (577 nm) laser
Arm Description
scatter laser indirect ophthalmoscopy pan retinal photocoagulation
scatter laser indirect ophthalmoscopy pan retinal photocoagulation
Outcomes
Primary Outcome Measures
Perceived patient pain assessment
Assessed using a standardized Wong-Baker faces pain scale
Secondary Outcome Measures
Minimum power requirement to achieve moderate gray-white retinal burns
Time of treatment
Time required to treat with each laser
Full Information
NCT ID
NCT02995629
First Posted
December 5, 2016
Last Updated
December 13, 2016
Sponsor
Wills Eye
Collaborators
Mid Atlantic Retina
1. Study Identification
Unique Protocol Identification Number
NCT02995629
Brief Title
Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation
Official Title
Patient Comfort Using Green (532 nm) Versus Yellow (577 nm) Laser Indirect Ophthalmoscopy Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Mid Atlantic Retina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
As demonstrated in the Diabetic Retinopathy Study (DRS), panretinal photocoagulation (PRP) reduces the risk of severe vision loss in patients with proliferative diabetic retinopathy. The DRS recommended that PRP treatment consist of 1,200 - 1,600 laser burns 500 µm in size, one half to one burn width apart, applied to the peripheral retina in a scatter fashion. Most patients who undergo PRP experience discomfort/pain during the procedure. Once present, pain can affect the number and quality of burns delivered and can indirectly increase the number of sessions required to complete the therapy.This may in turn adversely affect patient compliance. Although retrobulbar and peribulbar blocks can provide adequate anesthesia for PRP, these anesthetic methods carry rare but serious risks such as retrobulbar hemorrhage. Previous studies have explored other ways to reduce discomfort related to PRP, including optimization of laser settings, oral and topical analgesics, subconjunctival anesthesia, and even acupuncture.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy - High Risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
green (532 nm) laser
Arm Type
Experimental
Arm Description
scatter laser indirect ophthalmoscopy pan retinal photocoagulation
Arm Title
yellow (577 nm) laser
Arm Type
Experimental
Arm Description
scatter laser indirect ophthalmoscopy pan retinal photocoagulation
Intervention Type
Procedure
Intervention Name(s)
laser indirect ophthalmoscopy pan retinal photocoagulation
Other Intervention Name(s)
PRP laser
Intervention Description
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
Primary Outcome Measure Information:
Title
Perceived patient pain assessment
Description
Assessed using a standardized Wong-Baker faces pain scale
Time Frame
a single time point within 2 minutes of completing laser treatment
Secondary Outcome Measure Information:
Title
Minimum power requirement to achieve moderate gray-white retinal burns
Time Frame
During treatment
Title
Time of treatment
Description
Time required to treat with each laser
Time Frame
During treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Chiang, MD
Organizational Affiliation
Mid Atlantic Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid Atlantic Retina- Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Manuscript is under development.
Citations:
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7196564
Citation
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Citation
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Citation
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Citation
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Patient Comfort Using Green vs. Yellow Pan Retinal Photocoagulation
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